Trial Outcomes & Findings for Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients (NCT NCT01438229)

NCT ID: NCT01438229

Last Updated: 2019-02-05

Results Overview

All device or procedure related adverse events

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 47 participants
• Primary outcome timeframe: 24 months
• Results posted on: 2019-02-05

Participant Flow

Participant milestones

Measure	Renal Artery Ablation Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Overall Study STARTED	47
Overall Study Excluded Due to Renal Artery Anatomy	1
Overall Study Underwent Procedure	46
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy Study of Renal Artery Ablation in Resistant Hypertension Patients

Baseline characteristics by cohort

Measure	Renal Artery Ablation n=46 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Age, Continuous	60 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Race/Ethnicity, Customized White	45 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants
Region of Enrollment Greece	20 participants n=5 Participants
Region of Enrollment Australia	26 participants n=5 Participants
Body Mass Index	32 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants
Coronary Artery Disease Yes	9 participants n=5 Participants
Coronary Artery Disease No	37 participants n=5 Participants
Hyperlipidemia Yes	27 participants n=5 Participants
Hyperlipidemia No	19 participants n=5 Participants
Type II Diabetes Mellitus Yes	15 participants n=5 Participants
Type II Diabetes Mellitus No	31 participants n=5 Participants
Sleep Apnea Yes	14 participants n=5 Participants
Sleep Apnea No	32 participants n=5 Participants
eGFR	87 mL/min/1.73m^2 STANDARD_DEVIATION 19 • n=5 Participants
Serum Creatinine	78 mmol/L STANDARD_DEVIATION 17 • n=5 Participants
Cystatin C	1.1 mg/L STANDARD_DEVIATION 0.3 • n=5 Participants
Urine Albumin-to-Creatinine Ration	167.6 mg/g STANDARD_DEVIATION 493 • n=5 Participants
Number of Anti-Hypertensive Medications	4.7 medications STANDARD_DEVIATION 1.0 • n=5 Participants
Office Systolic Blood Pressure	176 mmHg STANDARD_DEVIATION 16 • n=5 Participants
Office Diastolic Blood Pressure	96 mmHg STANDARD_DEVIATION 14 • n=5 Participants
Heart Rate	71 beats per minute STANDARD_DEVIATION 12 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: All subjects receiving renal artery ablation procedure

All device or procedure related adverse events

Outcome measures

Measure	Renal Artery Ablation n=46 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Adverse Events	47.8 percentage of participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Population: Subjects with both baseline and 6M follow up office blood pressure measurements

Outcome measures

Measure	Renal Artery Ablation n=45 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Office Systolic Blood Pressure Change	-26 mmHg Standard Deviation 25

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6M

Outcome measures

Measure	Renal Artery Ablation n=45 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Office Diastolic BP Change	-10.5 mmHg Standard Deviation 12.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12M

Outcome measures

Measure	Renal Artery Ablation n=45 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Office Systolic BP Change	-26.7 mmHg Standard Deviation 20.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 18 months

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Office Systolic BP Change	-24.1 mmHg Standard Deviation 20.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 months

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Office Systolic BP Change	-29.1 mmHg Standard Deviation 26.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Outcome measures

Measure	Renal Artery Ablation n=45 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Office Diastolic BP Change	-10.7 mmHg Standard Deviation 12.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 18 months

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Office Diastolic BP Change	-10.1 mmHg Standard Deviation 11.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 months

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Office Diastolic BP Change	-13.3 mmHg Standard Deviation 14.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
24hr Ambulatory Systolic BP Change	-10.3 mmHg Standard Deviation 13.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.

Outcome measures

Measure	Renal Artery Ablation n=35 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
24hr Ambulatory Systolic BP Change	-6.7 mmHg Standard Deviation 14.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 months

Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.

Outcome measures

Measure	Renal Artery Ablation n=43 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
24hr Ambulatory Systolic BP Change	-13.2 mmHg Standard Deviation 15.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 6 months

Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
24hr Ambulatory Diastolic BP Change	-5.7 mmHg Standard Deviation 7.9

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 12 months

Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.

Outcome measures

Measure	Renal Artery Ablation n=35 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
24hr Ambulatory Diastolic BP Change	-4.3 mmHg Standard Deviation 8.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 24 months

Average of readings taken every half hour during the course of a 24hr period wearing the ambulatory blood pressure monitor. Includes only subjects who completed the test at both baseline and follow up. If a subject refused to wear the monitor they were excluded.

Outcome measures

Measure	Renal Artery Ablation n=43 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
24hr Ambulatory Diastolic BP Change	-7.5 mmHg Standard Deviation 8.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Outcome measures

Measure	Renal Artery Ablation n=46 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Urine Albumin to Creatinine Ratio	167.6 mg/g Standard Deviation 493

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Measure	Renal Artery Ablation n=45 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Urine Albumin to Creatinine Ratio	153.0 mg/g Standard Deviation 454

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Measure	Renal Artery Ablation n=45 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Urine Albumin to Creatinine Ratio	116.9 mg/g Standard Deviation 421

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Urine Albumin to Creatinine Ratio	131.0 mg/g Standard Deviation 358

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Urine Albumin to Creatinine Ratio	157.5 mg/g Standard Deviation 609

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Calculated using Modifide Diet in Renal Disease formula.

estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)

Outcome measures

Measure	Renal Artery Ablation n=46 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Estimated Glomular Filtration Rate	84.7 mL/min per 1.73m^2 Standard Deviation 18.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Calculated using Modifide Diet in Renal Disease formula.

estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)

Outcome measures

Measure	Renal Artery Ablation n=45 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Estimated Glomular Filtration Rate	79.8 mL/min per 1.73m^2 Standard Deviation 19.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Calculated using Modifide Diet in Renal Disease formula.

estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)

Outcome measures

Measure	Renal Artery Ablation n=45 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Estimated Glomular Filtration Rate	84.2 mL/min per 1.73m^2 Standard Deviation 20.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Calculated using Modifide Diet in Renal Disease formula.

estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Estimated Glomular Filtration Rate	75.5 mL/min per 1.73m^2 Standard Deviation 18.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Calculated using Modifide Diet in Renal Disease formula.

estimated GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female)

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Estimated Glomular Filtration Rate	76.4 mL/min per 1.73m^2 Standard Deviation 25.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Outcome measures

Measure	Renal Artery Ablation n=46 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Cystatin C	1.1 mg/L Standard Deviation 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months

Outcome measures

Measure	Renal Artery Ablation n=45 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Cystatin C	1.0 mg/L Standard Deviation 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Outcome measures

Measure	Renal Artery Ablation n=45 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Cystatin C	0.9 mg/L Standard Deviation 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 18 months

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Cystatin C	1.1 mg/L Standard Deviation 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 months

Outcome measures

Measure	Renal Artery Ablation n=44 Participants Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Cystatin C	1.3 mg/L Standard Deviation 0.4

Adverse Events

Renal Artery Ablation

Serious events: 14 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Renal Artery Ablation n=46 participants at risk Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
General disorders Hypotension (Procedure Related)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Renal and urinary disorders Hypertensive Renal Disease Progression (Device and Procedure Related)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Vascular disorders Renal Artery Stenosis (Device and Procedure Related)	2.2% 1/46 • Number of events 2 • 24 months Events adjudicated by an independent clinical events committee.
General disorders ACCELERATED HYPERTENSION (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Cardiac disorders ACUTE NSTEMI (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Renal and urinary disorders ACUTE RENAL FAILURE (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders ATYPICAL CHEST PAIN (Unrelated)	6.5% 3/46 • Number of events 3 • 24 months Events adjudicated by an independent clinical events committee.
General disorders BACK PAIN (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Vascular disorders CEREBROVASCULAR ACCIDENT (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders CLAUDICATION (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Metabolism and nutrition disorders GOUT (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders HEADACHE (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Cardiac disorders HEART FAILURE (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders HYPERTENSIVE RENAL DISEASE PROGRESSION (Unrelated)	4.3% 2/46 • Number of events 2 • 24 months Events adjudicated by an independent clinical events committee.
Injury, poisoning and procedural complications LEG TRAUMA (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Infections and infestations LEG WOUND CELLULITIS (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Musculoskeletal and connective tissue disorders LUMBAR DISC DISEASE (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MELANOMA (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC CANCER (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders PANCREATITIS (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Infections and infestations VIRAL ILLNESS (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.

Other adverse events

Measure	Renal Artery Ablation n=46 participants at risk Catheter-based RF ablation in renal artery St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery
Cardiac disorders BRADYCARDIA (Procedure Related)	4.3% 2/46 • Number of events 2 • 24 months Events adjudicated by an independent clinical events committee.
Blood and lymphatic system disorders HEMATOMA (Procedure Related)	15.2% 7/46 • Number of events 7 • 24 months Events adjudicated by an independent clinical events committee.
General disorders HYPOTENSION (Procedure Related)	6.5% 3/46 • Number of events 3 • 24 months Events adjudicated by an independent clinical events committee.
Gastrointestinal disorders NAUSEA/VOMITING (Procedure Related)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders PAIN (Procedure Related)	4.3% 2/46 • Number of events 2 • 24 months Events adjudicated by an independent clinical events committee.
General disorders VASOVAGAL RESPONSE (Procedure Related)	4.3% 2/46 • Number of events 3 • 24 months Events adjudicated by an independent clinical events committee.
Blood and lymphatic system disorders HEMATOMA (Device and Procedure Related)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Renal and urinary disorders HYPERTENSIVE RENAL DISEASE PROGRESSION (Device and Procedure Related)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders PAIN (Device and Procedure Related)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Vascular disorders RENAL ARTERY STENOSIS (Device and Procedure Related)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Renal and urinary disorders TRANSIENT HEMATURIA/DISCOLORED URINE (Device and Procedure Related)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Vascular disorders VASOSPASM (Device and Procedure Related)	15.2% 7/46 • Number of events 12 • 24 months Events adjudicated by an independent clinical events committee.
Immune system disorders ALLERGIC REACTION (Unrelated)	2.2% 1/46 • Number of events 2 • 24 months Events adjudicated by an independent clinical events committee.
General disorders ARM TREMOR (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders BACK PAIN (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Injury, poisoning and procedural complications BROKEN FINGERS (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Metabolism and nutrition disorders DIABETES (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders DIZZINESS (Unrelated)	4.3% 2/46 • Number of events 2 • 24 months Events adjudicated by an independent clinical events committee.
General disorders EDEMA (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Cardiac disorders FIRST DEGREE AV BLOCK (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders HEADACHE (Unrelated)	6.5% 3/46 • Number of events 4 • 24 months Events adjudicated by an independent clinical events committee.
General disorders HYPERKALEMIA (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders HYPERTENSIVE HEADACHES (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Cardiac disorders HYPERTENSIVE RELATED HEART FAILURE (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Renal and urinary disorders HYPERTENSIVE RENAL DISEASE PROGRESSION (Unrelated)	4.3% 2/46 • Number of events 2 • 24 months Events adjudicated by an independent clinical events committee.
General disorders HYPOKALEMIA (Unrelated)	4.3% 2/46 • Number of events 2 • 24 months Events adjudicated by an independent clinical events committee.
General disorders HYPOTENSION (Unrelated)	4.3% 2/46 • Number of events 2 • 24 months Events adjudicated by an independent clinical events committee.
Infections and infestations INFECTION (Unrelated)	8.7% 4/46 • Number of events 5 • 24 months Events adjudicated by an independent clinical events committee.
General disorders PAIN (Unrelated)	4.3% 2/46 • Number of events 2 • 24 months Events adjudicated by an independent clinical events committee.
General disorders PARA-AORTIC LYMPADENOPATHY (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Infections and infestations PNEUMONIA (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Renal and urinary disorders PROTEINURIA (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN CANCER (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
Cardiac disorders SUPRAVENTRUCULAR TACHYCARDIA (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.
General disorders TONSILLITIS (Unrelated)	2.2% 1/46 • Number of events 1 • 24 months Events adjudicated by an independent clinical events committee.

Additional Information

Steven Madej

St. Jude Medical

Phone: 651-756-2230

Email: smadej@sjm.com

Results disclosure agreements

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

Restriction type: LTE60