Trial Outcomes & Findings for IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioN (NCT NCT01705080)

NCT ID: NCT01705080

Last Updated: 2021-05-27

Results Overview

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

• Recruitment status: TERMINATED
• Target enrollment: 276 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2021-05-27

Participant Flow

A total of 276 subjects who underwent renal artery ablation fell into the analysis population of three predefined arms at 33 investigational sites located throughout Europe and Australia. The enrollment began on January 2013 and the last subject was enrolled on 06 September, 2016. The patients last follow-up visit occurred on 27 November, 2019.

Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.

Participant milestones

Measure	A - EnligHTN for Severe Resistant HTN * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Overall Study STARTED	147	101	28
Overall Study Renal Artery Ablation Procedure	147	101	28
Overall Study Discharge Following Renal Artery Ablation Procedure	147	100	28
Overall Study COMPLETED	72	49	12
Overall Study NOT COMPLETED	75	52	16

Reasons for withdrawal

Measure	A - EnligHTN for Severe Resistant HTN * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Overall Study Missed visit	10	4	1
Overall Study Death	4	4	6
Overall Study Withdrawal by Subject	61	44	9

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	A - EnligHTN for Severe Resistant HTN n=147 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=101 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=28 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	Total n=276 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 10.0 • n=147 Participants	58.0 years STANDARD_DEVIATION 11.8 • n=101 Participants	68.5 years STANDARD_DEVIATION 8.0 • n=28 Participants	60.9 years STANDARD_DEVIATION 10.9 • n=276 Participants
Sex: Female, Male Female	64 Participants n=147 Participants	26 Participants n=101 Participants	10 Participants n=28 Participants	100 Participants n=276 Participants
Sex: Female, Male Male	83 Participants n=147 Participants	75 Participants n=101 Participants	18 Participants n=28 Participants	176 Participants n=276 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Office Blood Pressure Systolic	180.4 mmHg STANDARD_DEVIATION 22.3 • n=147 Participants	160.8 mmHg STANDARD_DEVIATION 17.5 • n=101 Participants	177.3 mmHg STANDARD_DEVIATION 22.3 • n=28 Participants	172.9 mmHg STANDARD_DEVIATION 22.6 • n=276 Participants
Office Blood Pressure Diastolic	97.1 mmHg STANDARD_DEVIATION 16.3 • n=147 Participants	91.2 mmHg STANDARD_DEVIATION 13.3 • n=101 Participants	90.6 mmHg STANDARD_DEVIATION 13.2 • n=28 Participants	94.3 mmHg STANDARD_DEVIATION 15.2 • n=276 Participants
24-hour ambulatory blood pressure Systolic	159.0 mmHg STANDARD_DEVIATION 16.3 • n=135 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	147.4 mmHg STANDARD_DEVIATION 12.3 • n=93 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	161.8 mmHg STANDARD_DEVIATION 19.3 • n=24 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	155.0 mmHg STANDARD_DEVIATION 16.3 • n=252 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
24-hour ambulatory blood pressure Diastolic	88.9 mmHg STANDARD_DEVIATION 13.1 • n=135 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	87.0 mmHg STANDARD_DEVIATION 14.4 • n=93 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	82.9 mmHg STANDARD_DEVIATION 15.6 • n=24 Participants • The number of participants analyzed includes subjects who were available at that time of analysis	87.6 mmHg STANDARD_DEVIATION 13.9 • n=252 Participants • The number of participants analyzed includes subjects who were available at that time of analysis

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=142 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=96 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=27 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months Baseline	179.9 mmHg Standard Deviation 22.3	160.8 mmHg Standard Deviation 17.9	177.1 mmHg Standard Deviation 22.7
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months Change from baseline to 6 months	-16.7 mmHg Standard Deviation 26.7	-12.9 mmHg Standard Deviation 21.8	-18.3 mmHg Standard Deviation 25.8
Mean Reduction in Office Systolic Blood Pressure From Baseline to 6 Months 6 Months	163.2 mmHg Standard Deviation 25.1	147.9 mmHg Standard Deviation 17.2	158.7 mmHg Standard Deviation 21.9

SECONDARY outcome

Timeframe: 30 days post procedure

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The peri-procedural events occurring within 30 days post procedure were summarized as the percentage of the number of participants with peri-procedural events within 30 days post procedure compared to the number of participants at baseline for that population.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=147 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=101 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=28 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Acute Safety: Percentage of Participants With Peri-procedural Events Within 30 Days Post-procedure	49 Participants	37 Participants	8 Participants

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per Renal Artery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed on the time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=147 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=101 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=28 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Midterm Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 6 Months	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Confirmatory visit to 6 months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=131 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=93 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=27 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months Confirmatory visit	80.2 mL/min/1.73m^2 Standard Deviation 20.2	78.6 mL/min/1.73m^2 Standard Deviation 17.6	35.3 mL/min/1.73m^2 Standard Deviation 8.2
Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months 6 months	79.5 mL/min/1.73m^2 Standard Deviation 24.7	79.6 mL/min/1.73m^2 Standard Deviation 19.6	41.3 mL/min/1.73m^2 Standard Deviation 12.7
Midterm Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 6 Months Change from confirmatory visit to 6 months	-0.7 mL/min/1.73m^2 Standard Deviation 14.4	1.1 mL/min/1.73m^2 Standard Deviation 13.5	5.9 mL/min/1.73m^2 Standard Deviation 11.6

SECONDARY outcome

Timeframe: 2 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=147 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=101 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=28 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 2 Years	2 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 5 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The new renal artery stenosis (>50%) and/or aneurysm at the site of ablation per RenalArtery Imaging (CT/MR) was summarized at each follow-up visit as the percentage of patients who have stenosis and/or aneurysm. Kaplan-meier analysis was performed onthe time to the first new renal artery stenosis and/or aneurysm at the site of ablation, as appropriate.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=147 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=101 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=28 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Long Term Safety: Percentage of Participants With New Renal Artery Stenosis and/or Aneurysm at Ablation Site at 5 Years	3 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Confirmatory visit to 2 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=103 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=81 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=20 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years Confirmatory visit	79.4 mL/min/1.73m^2 Standard Deviation 17.4	78.4 mL/min/1.73m^2 Standard Deviation 19.0	36.3 mL/min/1.73m^2 Standard Deviation 8.2
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years 2 years	76.4 mL/min/1.73m^2 Standard Deviation 21.6	77.7 mL/min/1.73m^2 Standard Deviation 19.0	41.1 mL/min/1.73m^2 Standard Deviation 14.1
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 2 Years Change from confirmatory visit to 2 years	-3.0 mL/min/1.73m^2 Standard Deviation 15.8	-0.7 mL/min/1.73m^2 Standard Deviation 14.9	4.8 mL/min/1.73m^2 Standard Deviation 13.2

SECONDARY outcome

Timeframe: Confirmatory visit to 5 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Renal function change based on eGFR was summarized by computing the change of the eGFR at each follow-up visit compared to baseline for each patient with data available in both time points and calculating the mean and standard deviation of the eGFR change at those intervals.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=63 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=43 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=12 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years Confirmatory visit	77.6 mL/min/1.73 m^2 Standard Deviation 14.7	80.8 mL/min/1.73 m^2 Standard Deviation 17.2	38.6 mL/min/1.73 m^2 Standard Deviation 7.5
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years 5 years	67.9 mL/min/1.73 m^2 Standard Deviation 20.0	77.0 mL/min/1.73 m^2 Standard Deviation 18.6	37.5 mL/min/1.73 m^2 Standard Deviation 16.5
Long Term Safety: Mean Change in eGFR (mL/Min/1.73m²) From Confirmatory Visit to 5 Years Change from confirmatory visit to 5 years	-9.7 mL/min/1.73 m^2 Standard Deviation 17.3	-3.8 mL/min/1.73 m^2 Standard Deviation 15.7	-1.1 mL/min/1.73 m^2 Standard Deviation 14.5

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=121 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=85 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=21 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months 6 months	151.2 mmHg Standard Deviation 18.2	142.7 mmHg Standard Deviation 17.3	152.2 mmHg Standard Deviation 15.9
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months Baseline	158.3 mmHg Standard Deviation 15.7	147.0 mmHg Standard Deviation 12.1	160.4 mmHg Standard Deviation 18.9
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 6 Months Change from baseline to 6 months	-7.1 mmHg Standard Deviation 16.5	-4.3 mmHg Standard Deviation 17.1	-8.1 mmHg Standard Deviation 24.6

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=121 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=85 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=21 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months Baseline	88.8 mmHg Standard Deviation 12.7	86.8 mmHg Standard Deviation 14.3	83.3 mmHg Standard Deviation 15.8
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months 6 months	85.5 mmHg Standard Deviation 12.1	83.0 mmHg Standard Deviation 12.5	78.1 mmHg Standard Deviation 13.9
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 6 Months Change from baseline to 6 months	-3.3 mmHg Standard Deviation 9.3	-3.8 mmHg Standard Deviation 13.4	-5.1 mmHg Standard Deviation 13.1

SECONDARY outcome

Timeframe: Baseline to 6 months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=142 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=96 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=27 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months Baseline	97.0 mmHg Standard Deviation 16.2	91.2 mmHg Standard Deviation 13.6	91.0 mmHg Standard Deviation 13.3
Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months 6 months	89.6 mmHg Standard Deviation 15.6	86.0 mmHg Standard Deviation 13.4	77.9 mmHg Standard Deviation 14.4
Mean Change in Office Diastolic Blood Pressure From Baseline to 6 Months Change from baseline to 6 months	-7.4 mmHg Standard Deviation 13.9	-5.2 mmHg Standard Deviation 12.2	-13.1 mmHg Standard Deviation 10.1

SECONDARY outcome

Timeframe: 6 months

Population: The number of participants analyzed includes subjects who were available at the time of analysis

The percentage of participants achieved office systolic blood pressure <140 mmHg at 6 months visit was computed as the percentage of the ratio of number of participants who achievied office systolic blood pressure <140 mmHg at 6 months visit to the number of participants with data available in 6 months visit.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=142 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=96 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=27 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Percentage of Participants Achieved Office Systolic Blood Pressure < 140 mmHg at 6 Months	19 Participants	27 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline to 1 year

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=132 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=94 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=26 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation Baseline	180.0 mmHg Standard Deviation 22.4	160.1 mmHg Standard Deviation 17.6	176.8 mmHg Standard Deviation 23.0
Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation 1 year	166.4 mmHg Standard Deviation 25.6	147.8 mmHg Standard Deviation 20.8	159.8 mmHg Standard Deviation 26.6
Mean Change in Office Systolic Blood Pressure From Baseline to 1 Year Post Denervation Change from baseline to 1 year	-13.6 mmHg Standard Deviation 26.6	-12.3 mmHg Standard Deviation 22.6	-17.0 mmHg Standard Deviation 28.7

SECONDARY outcome

Timeframe: Baseline to 2 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=117 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=85 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=23 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation Baseline	178.7 mmHg Standard Deviation 22.0	158.5 mmHg Standard Deviation 16.6	178.0 mmHg Standard Deviation 22.4
Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation 2 years	160.6 mmHg Standard Deviation 26.5	144.3 mmHg Standard Deviation 19.5	153.1 mmHg Standard Deviation 17.5
Mean Change in Office Systolic Blood Pressure From Baseline to 2 Years Post Denervation Change from baseline to 2 years	-18.1 mmHg Standard Deviation 29.0	-14.2 mmHg Standard Deviation 20.9	-24.8 mmHg Standard Deviation 27.0

SECONDARY outcome

Timeframe: Baseline to 3 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=97 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=72 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=20 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation Baseline	179.3 mmHg Standard Deviation 21.9	160.7 mmHg Standard Deviation 17.5	179.0 mmHg Standard Deviation 23.7
Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation 3 years	159.1 mmHg Standard Deviation 28.5	143.8 mmHg Standard Deviation 19.4	151.2 mmHg Standard Deviation 21.3
Mean Change in Office Systolic Blood Pressure From Baseline to 3 Years Post Denervation Change from baseline to 3 years	-20.2 mmHg Standard Deviation 34.1	-16.9 mmHg Standard Deviation 23.1	-27.8 mmHg Standard Deviation 28.1

SECONDARY outcome

Timeframe: Baseline to 4 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=90 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=68 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=18 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation Baseline	177.7 mmHg Standard Deviation 21.8	157.6 mmHg Standard Deviation 15.4	180.4 mmHg Standard Deviation 24.1
Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation 4 years	156.2 mmHg Standard Deviation 28.8	144.6 mmHg Standard Deviation 25.3	146.9 mmHg Standard Deviation 23.5
Mean Change in Office Systolic Blood Pressure From Baseline to 4 Years Post Denervation Change from baseline to 4 years	-21.5 mmHg Standard Deviation 35.4	-13.0 mmHg Standard Deviation 24.9	-33.5 mmHg Standard Deviation 24.4

SECONDARY outcome

Timeframe: Baseline to 5 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=71 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=49 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=12 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation Baseline	176.2 mmHg Standard Deviation 20.3	160.2 mmHg Standard Deviation 16.3	184.8 mmHg Standard Deviation 24.6
Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation 5 years	151.8 mmHg Standard Deviation 22.6	144.4 mmHg Standard Deviation 21.8	152.8 mmHg Standard Deviation 19.1
Mean Change in Office Systolic Blood Pressure From Baseline to 5 Years Post Denervation Change from baseline to 5 years	-24.4 mmHg Standard Deviation 28.4	-15.7 mmHg Standard Deviation 24.8	-32.0 mmHg Standard Deviation 25.7

SECONDARY outcome

Timeframe: Baseline to 1 year

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=132 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=94 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=26 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation Baseline	97.8 mmHg Standard Deviation 16.6	91.0 mmHg Standard Deviation 13.5	91.5 mmHg Standard Deviation 13.3
Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation 1 year	90.9 mmHg Standard Deviation 17.6	85.5 mmHg Standard Deviation 13.7	78.5 mmHg Standard Deviation 14.2
Mean Change in Office Diastolic Blood Pressure From Baseline to 1 Year Post Denervation Change from baseline to 1 year	-6.9 mmHg Standard Deviation 15.0	-5.5 mmHg Standard Deviation 13.2	-13.0 mmHg Standard Deviation 13.3

SECONDARY outcome

Timeframe: Baseline to 2 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=117 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=85 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=23 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation Baseline	97.1 mmHg Standard Deviation 16.8	91.0 mmHg Standard Deviation 12.7	92.0 mmHg Standard Deviation 12.9
Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation 2 years	88.2 mmHg Standard Deviation 16.6	83.4 mmHg Standard Deviation 13.0	75.2 mmHg Standard Deviation 14.3
Mean Change in Office Diastolic Blood Pressure From Baseline to 2 Years Post Denervation Change from baseline to 2 years	-8.9 mmHg Standard Deviation 16.5	-7.6 mmHg Standard Deviation 12.3	-16.8 mmHg Standard Deviation 14.7

SECONDARY outcome

Timeframe: Baseline to 3 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=97 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=72 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=20 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation Baseline	98.6 mmHg Standard Deviation 17.5	92.0 mmHg Standard Deviation 13.2	91.3 mmHg Standard Deviation 13.3
Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation 3 years	87.1 mmHg Standard Deviation 15.8	82.9 mmHg Standard Deviation 12.8	76.6 mmHg Standard Deviation 14.8
Mean Change in Office Diastolic Blood Pressure From Baseline to 3 Years Post Denervation Change from baseline to 3 years	-11.5 mmHg Standard Deviation 18.4	-9.0 mmHg Standard Deviation 12.6	-14.7 mmHg Standard Deviation 14.5

SECONDARY outcome

Timeframe: Baseline to 4 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=90 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=68 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=18 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation Baseline	97.5 mmHg Standard Deviation 17.5	91.0 mmHg Standard Deviation 12.7	93.2 mmHg Standard Deviation 11.2
Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation 4 years	86.2 mmHg Standard Deviation 13.5	85.2 mmHg Standard Deviation 16.3	77.2 mmHg Standard Deviation 12.3
Mean Change in Office Diastolic Blood Pressure From Baseline to 4 Years Post Denervation Change from baseline to 4 years	-11.3 mmHg Standard Deviation 18.2	-5.9 mmHg Standard Deviation 13.4	-16.0 mmHg Standard Deviation 9.8

SECONDARY outcome

Timeframe: Baseline to 5 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

Office blood pressure corresponds to the blood pressure measured by the doctor or the nurse/staff in the office or in the clinic during the participant visit. Office Blood Pressure measurements was recorded as the average Blood Pressure of three measurements. If there was a change in medication after the office Blood Pressure assessment was completed an additional set of office Blood Pressure measurements was performed.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=71 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=49 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=12 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation Baseline	98.4 mmHg Standard Deviation 17.3	93.1 mmHg Standard Deviation 12.8	95.8 mmHg Standard Deviation 13.0
Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation 5 years	84.9 mmHg Standard Deviation 11.7	85.1 mmHg Standard Deviation 16.1	78.7 mmHg Standard Deviation 12.7
Mean Change in Office Diastolic Blood Pressure From Baseline to 5 Years Post Denervation Change from baseline to 5 years	-13.4 mmHg Standard Deviation 14.4	-8.0 mmHg Standard Deviation 14.5	-17.1 mmHg Standard Deviation 14.0

SECONDARY outcome

Timeframe: Baseline to 1 year

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=105 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=78 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=19 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation Baseline	159.1 mmHg Standard Deviation 16.1	146.8 mmHg Standard Deviation 11.4	163.9 mmHg Standard Deviation 18.8
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation 1 year	149.0 mmHg Standard Deviation 18.7	141.7 mmHg Standard Deviation 17.3	148.2 mmHg Standard Deviation 21.1
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 1 Year Post Denervation Change from baseline to 1 year	-10.1 mmHg Standard Deviation 18.3	-5.1 mmHg Standard Deviation 16.8	-15.8 mmHg Standard Deviation 24.3

SECONDARY outcome

Timeframe: Baseline to 2 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=92 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=70 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=16 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation Baseline	158.5 mmHg Standard Deviation 15.8	146.7 mmHg Standard Deviation 11.8	159.9 mmHg Standard Deviation 16.8
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation 2 years	148.0 mmHg Standard Deviation 17.2	139.5 mmHg Standard Deviation 15.0	144.0 mmHg Standard Deviation 16.7
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 2 Years Post Denervation Change from baseline to 2 years	-10.5 mmHg Standard Deviation 18.6	-7.2 mmHg Standard Deviation 16.0	-15.9 mmHg Standard Deviation 18.7

SECONDARY outcome

Timeframe: Baseline to 3 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=72 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=57 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=11 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation Change from baseline to 3 years	-13.6 mmHg Standard Deviation 21.5	-7.2 mmHg Standard Deviation 18.8	-4.8 mmHg Standard Deviation 20.5
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation Baseline	157.8 mmHg Standard Deviation 15.9	147.0 mmHg Standard Deviation 11.9	156.0 mmHg Standard Deviation 14.8
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 3 Years Post Denervation 3 years	144.2 mmHg Standard Deviation 19.3	139.8 mmHg Standard Deviation 18.1	151.2 mmHg Standard Deviation 18.8

SECONDARY outcome

Timeframe: Baseline to 4 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=67 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=56 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=12 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation Change from baseline to 4 years	-14.9 mmHg Standard Deviation 22.4	-8.5 mmHg Standard Deviation 17.8	-6.8 mmHg Standard Deviation 29.6
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation Baseline	157.2 mmHg Standard Deviation 14.5	146.3 mmHg Standard Deviation 11.7	158.4 mmHg Standard Deviation 16.4
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 4 Years Post Denervation 4 years	142.3 mmHg Standard Deviation 19.6	137.9 mmHg Standard Deviation 19.1	151.6 mmHg Standard Deviation 21.2

SECONDARY outcome

Timeframe: Baseline to 5 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=50 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=35 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=10 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation Baseline	155.2 mmHg Standard Deviation 14.9	143.7 mmHg Standard Deviation 9.8	158.0 mmHg Standard Deviation 18.1
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation 5 years	140.0 mmHg Standard Deviation 17.8	133.3 mmHg Standard Deviation 13.4	146.3 mmHg Standard Deviation 26.3
Mean Change in Ambulatory Systolic Blood Pressure From Baseline to 5 Years Post Denervation Change from baseline to 5 years	-15.1 mmHg Standard Deviation 22.0	-10.4 mmHg Standard Deviation 11.8	-11.7 mmHg Standard Deviation 33.4

SECONDARY outcome

Timeframe: Baseline to 1 year

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=105 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=78 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=19 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation Baseline	89.1 mmHg Standard Deviation 12.9	86.2 mmHg Standard Deviation 14.1	85.4 mmHg Standard Deviation 16.3
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation 1 year	84.7 mmHg Standard Deviation 12.0	81.9 mmHg Standard Deviation 12.2	77.7 mmHg Standard Deviation 12.2
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 1 Year Post Denervation Change from baseline to 1 year	-4.4 mmHg Standard Deviation 10.4	-4.4 mmHg Standard Deviation 13.4	-7.6 mmHg Standard Deviation 14.1

SECONDARY outcome

Timeframe: Baseline to 2 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=92 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=70 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=16 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation Change from baseline to 2 years	-4.8 mmHg Standard Deviation 10.4	-5.0 mmHg Standard Deviation 12.3	-7.6 mmHg Standard Deviation 10.8
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation Baseline	88.6 mmHg Standard Deviation 13.2	86.6 mmHg Standard Deviation 14.2	84.6 mmHg Standard Deviation 16.9
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 2 Years Post Denervation 2 years	83.8 mmHg Standard Deviation 12.0	81.5 mmHg Standard Deviation 11.4	76.9 mmHg Standard Deviation 14.8

SECONDARY outcome

Timeframe: Baseline to 3 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=72 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=57 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=11 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation Baseline	89.0 mmHg Standard Deviation 12.9	87.7 mmHg Standard Deviation 14.7	81.7 mmHg Standard Deviation 14.7
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation 3 years	81.3 mmHg Standard Deviation 11.2	81.2 mmHg Standard Deviation 12.9	76.8 mmHg Standard Deviation 12.9
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 3 Years Post Denervation Change from baseline to 3 years	-7.7 mmHg Standard Deviation 13.8	-6.5 mmHg Standard Deviation 13.9	-4.9 mmHg Standard Deviation 10.5

SECONDARY outcome

Timeframe: Baseline to 4 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=67 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=56 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=12 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation Baseline	88.4 mmHg Standard Deviation 12.5	87.6 mmHg Standard Deviation 14.8	82.1 mmHg Standard Deviation 14.1
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation 4 years	80.3 mmHg Standard Deviation 12.5	80.9 mmHg Standard Deviation 13.4	78.1 mmHg Standard Deviation 12.6
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 4 Years Post Denervation Change from baseline to 4 years	-8.1 mmHg Standard Deviation 14.6	-6.6 mmHg Standard Deviation 14.5	-4.0 mmHg Standard Deviation 11.6

SECONDARY outcome

Timeframe: Baseline to 5 years

Population: The number of participants analyzed includes subjects who were available at the time of analysis

24-hour Ambulatory Blood Pressure measurements were taken according to Standard Joint National Committee VII Guidelines / ESC and ESH Guidelines at each follow-up visit. In the 24-hour blood pressure monitoring, the blood pressure of patient was measured every 30 minutes during the daytime and every 60 minutes during the night time. When using ABP, it was ensured that at least two measurements per hour are taken during the person's usual waking hours and 1 measurement per hour are taken during the person's usual night time hours. The average value of at least 14 measurements taken during the person's usual waking hours and average of at least 8 measurements taken during the person's usual sleeping hours were used for calculation of mean value.

Outcome measures

Measure	A - EnligHTN for Severe Resistant HTN n=50 Participants * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=35 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=10 Participants * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation Baseline	87.1 mmHg Standard Deviation 13.1	87.9 mmHg Standard Deviation 15.6	83.2 mmHg Standard Deviation 14.8
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation 5 years	79.2 mmHg Standard Deviation 10.7	78.5 mmHg Standard Deviation 11.1	76.0 mmHg Standard Deviation 14.4
Mean Change in Ambulatory Diastolic Blood Pressure From Baseline to 5 Years Post Denervation Change from baseline to 5 years	-7.8 mmHg Standard Deviation 12.6	-9.4 mmHg Standard Deviation 13.1	-7.2 mmHg Standard Deviation 13.1

Adverse Events

A - EnligHTN for Severe Resistant HTN

Serious events: 72 serious events

Other events: 40 other events

Deaths: 4 deaths

B - EnligHTN for Resistant HTN

Serious events: 38 serious events

Other events: 26 other events

Deaths: 4 deaths

C - EnligHTN for Resistant HTN & CKD

Serious events: 18 serious events

Other events: 9 other events

Deaths: 6 deaths

Serious adverse events

Measure	A - EnligHTN for Severe Resistant HTN n=147 participants at risk * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=101 participants at risk * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=28 participants at risk * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Ear and labyrinth disorders Hearing loss	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Unstable Angina	3.4% 5/147 • Number of events 7 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	4.0% 4/101 • Number of events 6 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders SVC Syndrome	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Second Degree Heart Block	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Angina Pectoris	0.68% 1/147 • Number of events 6 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Anterior Myocardial Infarction	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Aortic Valve Stenosis	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Atrial Fibrillation	2.0% 3/147 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.0% 3/101 • Number of events 4 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	7.1% 2/28 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Atrial Flutter	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Cardiac Arrest	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Cardiomyopathy	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Carotid Aneurysm-Aneurysm Of Left Internal Carotid Artery	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Chest Pain	4.8% 7/147 • Number of events 7 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	4.0% 4/101 • Number of events 4 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	7.1% 2/28 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Congestive Heart Failure	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Coronary Artery Disease	2.0% 3/147 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Decompensated Heart Failure	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders First Degree Heart/AV Block/Cardiac Arrhythmia - 1st degree AV Block	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Heart Failure	2.7% 4/147 • Number of events 5 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	10.7% 3/28 • Number of events 4 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Myocardial Infarction	3.4% 5/147 • Number of events 8 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	5.0% 5/101 • Number of events 5 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	10.7% 3/28 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Palpitations	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Paroxysmal Supraventricular Tachycardia	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Pericardial Effusion	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Pericarditis	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Persistent Atrial Fibrillation	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Right Ventricular Failure	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders ST Segment Changes	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Eye disorders Retinal Tear	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Gastrointestinal disorders Abdominal Pain	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Gastrointestinal disorders Acute Abdomen	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Gastrointestinal disorders Diverticulitis	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Gastrointestinal disorders Gastritis	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Gastrointestinal disorders Gastrointestinal Bleeding	0.68% 1/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Gastrointestinal disorders Perforated Appendix	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Fall	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Headache	0.68% 1/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Lacerations	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Melena	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Other-Bladder	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Other-Death	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Other-Death Of Unknown Cause	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Other-Hemorrhagic Lymphocele	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Other-Non-Specifc Acute Lung Injury	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Shock	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Syncope	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Vertigo	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Acute Pancreatitis	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Bacteremia	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Bacterial Infections	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Bacterial Infections of the Skin	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Chlamydial Pneumonia	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Cholecystitis	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Infected Cyst	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Influenza	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Pneumonia	2.0% 3/147 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	7.1% 2/28 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Pneumonia in the Compromised Host	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Sepsis	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Injury, poisoning and procedural complications Allergic Dye Reaction	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Injury, poisoning and procedural complications In-Stent Restenosis	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Metabolism and nutrition disorders Diabetes Mellitus	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Metabolism and nutrition disorders Hyperkalemia	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Ankle Fracture	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Back Pain	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Calf Pain	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Disc Protrusion	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Hip Fracture	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Tendon Tear	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Prostatic Hyperplasia (BPH)	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kidney Tumor	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic Cancer	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Chronic Subdural Hematoma	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Hemiparesis/Weakness	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Hemorrhagic Stroke	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Ischemic Stroke	2.7% 4/147 • Number of events 4 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Lumbar Spondylosis	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Seizure/Convulsions/Epilepsy	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Stroke	4.8% 7/147 • Number of events 9 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.0% 3/101 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Transient Ischemic Attack (TIA)	4.1% 6/147 • Number of events 6 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Acute Renal Failure	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Chronic Renal Failure	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Hematuria	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Kidney Pain/Flank Pain	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Renal Congestion-Urinary Obstruction-Renal Congestion	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Renal Failure	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	7.1% 2/28 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Ureteral Dysfunction	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Urethral Dysfunction	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Urinary Retention	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Urinary Tract Infections	0.68% 1/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Respiratory, thoracic and mediastinal disorders Acute Pulmonary Edema	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Respiratory, thoracic and mediastinal disorders Common Cold/Upper Respiratory Tract Infection	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	7.1% 2/28 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Respiratory, thoracic and mediastinal disorders Mediastinitis	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	2.0% 3/147 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	7.1% 2/28 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Skin and subcutaneous tissue disorders Cutaneous Abcesses	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Arterial Hypertension/Hypertension	6.8% 10/147 • Number of events 12 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	5.0% 5/101 • Number of events 7 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	7.1% 2/28 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Hypertensive Crisis	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Peripheral Arterial Occlusion	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Renal Artery Dissection	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Renal Artery Stenosis	4.1% 6/147 • Number of events 6 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.0% 3/101 • Number of events 4 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Renovascular Hypertension	0.68% 1/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Thrombus	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders VASC Bleeding	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders VASC Hematoma	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders VASC Pseudoaneurysm	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.0% 3/101 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Vasospasm	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Blood and lymphatic system disorders Anemias	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Blood and lymphatic system disorders Bleeding	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Blood and lymphatic system disorders Hemorrhage	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Blood and lymphatic system disorders Trauma	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.

Other adverse events

Measure	A - EnligHTN for Severe Resistant HTN n=147 participants at risk * Office systolic Blood Pressure ≥160 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	B - EnligHTN for Resistant HTN n=101 participants at risk * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated GFR ≥45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups	C - EnligHTN for Resistant HTN & CKD n=28 participants at risk * Office systolic Blood Pressure ≥140 mmHg * Participant is taking ≥3 anti-hypertensive medications (including 1 diuretic), or participant has documented drug intolerance to 2 or more of the 4 major classes of anti-hypertensives (ACE/ARB, Calcium Channel Blockers, Beta Blockers, or diuretic) and is unable to take 3 anti-hypertensive drugs. * Participant has an estimated ≥15 GFR \<45 mL/min per 1.73 m\^2 using the Modification of Diet in Renal Disease (MDRD) formula EnligHTN: Renal artery ablation with EnligHTN system used for all groups
Cardiac disorders Sick Sinus Syndrome	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Sinus Bradycardia/Sinus Bradycardia (Cardiac Arrhythmia)	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Eye disorders Eye Bleed	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Gastrointestinal disorders Abdominal Pain	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Gastrointestinal disorders Colon Polyps	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Gastrointestinal disorders Inguinal Hernia	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Gastrointestinal disorders Nausea	2.7% 4/147 • Number of events 4 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Discomfort	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Dizziness	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Edema	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Elective Procedure	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Elective Surgery	2.0% 3/147 • Number of events 4 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Headache	1.4% 2/147 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Numbness-Numbness In Right Thigh	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Other-Small Wedge Shaped Abnormalities In Both Kidneys In Keeping With Small Infarcts	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Angina Pectoris	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Coronary Artery Disease	2.0% 3/147 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Heart Failure	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Cardiac disorders Mobitz II Block	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Osteoarthritis/Degenerative Joint Disease	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign Mass	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Numbness	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Stroke	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Nervous system disorders Transient Ischemic Attack (TIA)	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Product Issues Device Malposition or Malfunction	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Abnormal Renal Function	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Hematuria	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Kidney Pain/Flank Pain	3.4% 5/147 • Number of events 5 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Renal Failure	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Renal and urinary disorders Urinary Retention	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Reproductive system and breast disorders Prostate Disease	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Respiratory, thoracic and mediastinal disorders Chest Tightness	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Respiratory, thoracic and mediastinal disorders Sinusitis	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Aortic Dissection	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Hematoma	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Hypotension	2.0% 3/147 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Orthostatic Hypotension	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Renal Artery Stenosis	4.8% 7/147 • Number of events 8 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders VASC Bleeding	2.7% 4/147 • Number of events 4 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders VASC Bruise	2.0% 3/147 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	2.0% 2/101 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	7.1% 2/28 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders VASC Drainage	6.1% 9/147 • Number of events 9 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.0% 3/101 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders VASC Hematoma	3.4% 5/147 • Number of events 5 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	5.0% 5/101 • Number of events 5 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders VASC Pain	4.8% 7/147 • Number of events 7 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	5.0% 5/101 • Number of events 6 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders VASC Pseudoaneurysm	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders VASC Vessel Perforation	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Vaso Vagal Response	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Vascular disorders Vasospasm	10.2% 15/147 • Number of events 17 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	11.9% 12/101 • Number of events 17 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 2 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
General disorders Pain	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Cellulitis	0.68% 1/147 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Pneumonia	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Infections and infestations Pneumonitis	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	3.6% 1/28 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Hip Pain	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Low Back Pain	2.0% 3/147 • Number of events 3 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/101 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.
Musculoskeletal and connective tissue disorders Muscle Twitch	0.00% 0/147 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.99% 1/101 • Number of events 1 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.	0.00% 0/28 • 5 years Among the 353 subjects who were screened initially, 66 subjects did not receive the renal artery ablation procedure, 11 subjects received procedure but did not satisfy the definition of any arm. The 11 subjects who received RND procedure were followed up for exploratory analysis and considered as "unassigned arm". Of these subjects, 5 subjects completed the study, 6 subjects were withdrawn prior to study completion. Hence they were excluded during the endpoint and safety analyses.

Additional Information

Steven Madej

Abbott

Phone: 651-756-2230

Email: smadej@sjm.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place