Trial Outcomes & Findings for EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension (NCT NCT01903187)
NCT ID: NCT01903187
Last Updated: 2019-02-15
Results Overview
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
6 months post randomization
Results posted on
2019-02-15
Participant Flow
Participant milestones
| Measure |
Renal Denervation
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
|
Sham Procedure
Sham procedure
Sham: Renal artery angiogram
|
|---|---|---|
|
Procedure
STARTED
|
2
|
2
|
|
Procedure
COMPLETED
|
2
|
2
|
|
Procedure
NOT COMPLETED
|
0
|
0
|
|
1 Month
STARTED
|
2
|
2
|
|
1 Month
COMPLETED
|
2
|
2
|
|
1 Month
NOT COMPLETED
|
0
|
0
|
|
3 Month
STARTED
|
2
|
0
|
|
3 Month
COMPLETED
|
2
|
0
|
|
3 Month
NOT COMPLETED
|
0
|
0
|
|
6 Month
STARTED
|
2
|
0
|
|
6 Month
COMPLETED
|
2
|
0
|
|
6 Month
NOT COMPLETED
|
0
|
0
|
|
12 Month
STARTED
|
2
|
0
|
|
12 Month
COMPLETED
|
2
|
0
|
|
12 Month
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension
Baseline characteristics by cohort
| Measure |
Renal Denervation
n=2 Participants
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
|
Sham Procedure
n=2 Participants
Sham procedure
Sham: Renal artery angiogram
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Height
|
172.9 centimeters
STANDARD_DEVIATION 14.1 • n=5 Participants
|
171.5 centimeters
STANDARD_DEVIATION 5.4 • n=7 Participants
|
172.2 centimeters
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Weight
|
81.0 kilograms
STANDARD_DEVIATION 18.4 • n=5 Participants
|
108.0 kilograms
STANDARD_DEVIATION 25.0 • n=7 Participants
|
94.5 kilograms
STANDARD_DEVIATION 23.7 • n=5 Participants
|
|
BMI
|
27.9 kg/m^2
STANDARD_DEVIATION 10.6 • n=5 Participants
|
36.5 kg/m^2
STANDARD_DEVIATION 6.2 • n=7 Participants
|
32.2 kg/m^2
STANDARD_DEVIATION 8.7 • n=5 Participants
|
|
Years with hypertension
|
30.5 years
STANDARD_DEVIATION 0.7 • n=5 Participants
|
36.0 years
STANDARD_DEVIATION 0 • n=7 Participants
|
32.3 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Coronary Artery Disease
Yes
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Coronary Artery Disease
No
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Renal Artery Stenosis
Yes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Renal Artery Stenosis
No
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Hyperlipidemia
Yes
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Hyperlipidemia
No
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Type II Diabetes
Yes
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Type II Diabetes
No
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Obstructive Sleep Apnea
Yes
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Obstructive Sleep Apnea
No
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
eGFR
|
91.0 mL/min/1.73 m2
STANDARD_DEVIATION 26.9 • n=5 Participants
|
71.5 mL/min/1.73 m2
STANDARD_DEVIATION 14.8 • n=7 Participants
|
81.3 mL/min/1.73 m2
STANDARD_DEVIATION 21.0 • n=5 Participants
|
|
Serum Creatinine
|
69.0 umol/L
STANDARD_DEVIATION 26.9 • n=5 Participants
|
83.0 umol/L
STANDARD_DEVIATION 1.4 • n=7 Participants
|
76.0 umol/L
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Cystatin C
|
0.76 mg/L
STANDARD_DEVIATION 0.25 • n=5 Participants
|
0.98 mg/L
STANDARD_DEVIATION 0.18 • n=7 Participants
|
0.87 mg/L
STANDARD_DEVIATION 0.22 • n=5 Participants
|
|
Urine Albumin to Creatinine Ratio
|
10.5 mg/g
STANDARD_DEVIATION 2.1 • n=5 Participants
|
98.0 mg/g
STANDARD_DEVIATION 106.1 • n=7 Participants
|
54.3 mg/g
STANDARD_DEVIATION 79.4 • n=5 Participants
|
|
Office Systolic BP
|
178.0 mmHg
STANDARD_DEVIATION 17.0 • n=5 Participants
|
199.5 mmHg
STANDARD_DEVIATION 34.6 • n=7 Participants
|
188.8 mmHg
STANDARD_DEVIATION 25.5 • n=5 Participants
|
|
Office Diastolic BP
|
111.5 mmHg
STANDARD_DEVIATION 4.9 • n=5 Participants
|
88.0 mmHg
STANDARD_DEVIATION 1.4 • n=7 Participants
|
99.8 mmHg
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Office Heart Rate
|
76.5 beats/minute
STANDARD_DEVIATION 12.0 • n=5 Participants
|
58.5 beats/minute
STANDARD_DEVIATION 7.8 • n=7 Participants
|
67.5 beats/minute
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
24-Hr Ambulatory Systolic BP
|
151.7 mmHg
STANDARD_DEVIATION 22.9 • n=5 Participants
|
155.3 mmHg
STANDARD_DEVIATION 4.3 • n=7 Participants
|
153.5 mmHg
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
24-Hr Ambulatory Diastolic BP
|
92.5 mmHg
STANDARD_DEVIATION 24.7 • n=5 Participants
|
75.4 mmHg
STANDARD_DEVIATION 1.4 • n=7 Participants
|
83.9 mmHg
STANDARD_DEVIATION 17.4 • n=5 Participants
|
|
24-Hr Ambulatory Heart Rate
|
68.2 beats/minute
STANDARD_DEVIATION 2.9 • n=5 Participants
|
60.5 beats/minute
STANDARD_DEVIATION 16.0 • n=7 Participants
|
64.3 beats/minute
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Daytime Ambulatory Systolic BP
|
161.4 mmHg
STANDARD_DEVIATION 27.0 • n=5 Participants
|
155.0 mmHg
STANDARD_DEVIATION 2.7 • n=7 Participants
|
158.2 mmHg
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Daytime Ambulatory Diastolic BP
|
99.8 mmHg
STANDARD_DEVIATION 27.6 • n=5 Participants
|
75.6 mmHg
STANDARD_DEVIATION 1.8 • n=7 Participants
|
87.7 mmHg
STANDARD_DEVIATION 21.2 • n=5 Participants
|
|
Daytime Ambulatory Heart Rate
|
69.4 beats/minute
STANDARD_DEVIATION 1.6 • n=5 Participants
|
60.6 beats/minute
STANDARD_DEVIATION 18.3 • n=7 Participants
|
65.0 beats/minute
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Number of Anti-hypertensive medications
|
4.0 number of anti-hypertensive medications
STANDARD_DEVIATION 1.4 • n=5 Participants
|
5.5 number of anti-hypertensive medications
STANDARD_DEVIATION 0.7 • n=7 Participants
|
4.8 number of anti-hypertensive medications
STANDARD_DEVIATION 1.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post randomizationPopulation: All subjects randomized to the EnligHTN procedure
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred.
Outcome measures
| Measure |
Renal Denervation
n=2 Participants
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
|
Sham Procedure
Sham procedure
Sham: Renal artery angiogram
|
|---|---|---|
|
The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC).
Proportion of Subjects with MAE
|
0 percentage of participants
|
—
|
|
The Primary Safety Endpoint Will be the Proportion of Subjects Who Experience Any Major Adverse Event (MAE) as Adjudicated by the Clinical Event Committee (CEC).
Proportion Subjects without MAE
|
100 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 6 months post randomizationPopulation: The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct a comparison between groups.
Outcome measures
| Measure |
Renal Denervation
n=2 Participants
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
|
Sham Procedure
Sham procedure
Sham: Renal artery angiogram
|
|---|---|---|
|
The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups
|
-22.5 mmHg
Standard Deviation 36
|
—
|
SECONDARY outcome
Timeframe: 6 months post randomizationPopulation: Subjects who received renal denervation
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
Outcome measures
| Measure |
Renal Denervation
n=2 Participants
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
|
Sham Procedure
Sham procedure
Sham: Renal artery angiogram
|
|---|---|---|
|
Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 months post randomizationPopulation: Subjects who received renal denervation
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
Outcome measures
| Measure |
Renal Denervation
n=2 Participants
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
|
Sham Procedure
Sham procedure
Sham: Renal artery angiogram
|
|---|---|---|
|
The Number of Subjects That Experience Each Type of MAE
All Cause Mortality
|
0 Participants
|
—
|
|
The Number of Subjects That Experience Each Type of MAE
End Stage Renal Disease (eGFR <15ml/min/m2)
|
0 Participants
|
—
|
|
The Number of Subjects That Experience Each Type of MAE
Significant Embolic Event
|
0 Participants
|
—
|
|
The Number of Subjects That Experience Each Type of MAE
Renal Artery Perforation
|
0 Participants
|
—
|
|
The Number of Subjects That Experience Each Type of MAE
Renal Artery Dissection
|
0 Participants
|
—
|
|
The Number of Subjects That Experience Each Type of MAE
Hypertensive Crisis
|
0 Participants
|
—
|
|
The Number of Subjects That Experience Each Type of MAE
Renal Artery Stenosis
|
0 Participants
|
—
|
|
The Number of Subjects That Experience Each Type of MAE
Vascular Access Site Complication
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 months post randomization, and all follow-up timepointsPopulation: Subjects who received renal denervation
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
Outcome measures
| Measure |
Renal Denervation
n=2 Participants
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
|
Sham Procedure
Sham procedure
Sham: Renal artery angiogram
|
|---|---|---|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥10mmHg SBP reduction from BL(6M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥10mmHg SBP reduction from BL(12M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥10mmHg SBP reduction from BL(18M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥10mmHg SBP reduction from BL(24M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥10mmHg SBP reduction from BL(30M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥10mmHg SBP reduction from BL(36M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥15mmHg SBP reduction from BL (6M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥15mmHg SBP reduction from BL (12M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥15mmHg SBP reduction from BL (18M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥15mmHg SBP reduction from BL (24M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥15mmHg SBP reduction from BL (30M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥15mmHg SBP reduction from BL (36M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥20mmHg SBP reduction from BL (6M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥20mmHg SBP reduction from BL (12M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥20mmHg SBP reduction from BL (18M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥20mmHg SBP reduction from BL (24M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥20mmHg SBP reduction from BL (30M)
|
1 Participants
|
—
|
|
Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Responders ≥20mmHg SBP reduction from BL (36M)
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: baseline, 6 months post randomization, and all follow-up timepointsPopulation: All subjects
The study enrollment was terminated early by the sponsor. This was not related to any safety issue. At the time enrollment was halted, only 2 treatment group randomizations had occurred, and sham group subjects were exited after their 1 month follow up visit. This was not enough to conduct the analysis.
Outcome measures
| Measure |
Renal Denervation
n=2 Participants
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
|
Sham Procedure
n=2 Participants
Sham procedure
Sham: Renal artery angiogram
|
|---|---|---|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
Baseline 24Hr Systolic
|
151.7 mmHg
Standard Deviation 22.9
|
155.3 mmHg
Standard Deviation 4.3
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
1 Month 24Hr Systolic
|
128.8 mmHg
Standard Deviation 1.3
|
155.5 mmHg
Standard Deviation 6.8
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
3 Month 24Hr Systolic
|
158.9 mmHg
Standard Deviation 50.8
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
6 Month 24Hr Systolic
|
124.7 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
12 Month 24Hr Systolic
|
121.3 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
18 Month 24Hr Systolic
|
133.6 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
24 Month 24Hr Systolic
|
123.1 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
30 Month 24Hr Systolic
|
123.2 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
36 Month 24Hr Systolic
|
121.5 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
Baseline 24Hr Diastolic
|
92.5 mmHg
Standard Deviation 24.7
|
75.4 mmHg
Standard Deviation 1.4
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
1 Month 24Hr Diastolic
|
78.8 mmHg
Standard Deviation 13.5
|
73.9 mmHg
Standard Deviation 4.9
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
3 Month 24Hr Diastolic
|
93.9 mmHg
Standard Deviation 37.8
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
6 Month 24Hr Diastolic
|
66.2 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
12 Month 24Hr Diastolic
|
67.3 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
18 Month 24Hr Diastolic
|
71.7 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
24 Month 24Hr Diastolic
|
65.2 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
30 Month 24Hr Diastolic
|
61.3 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
|
Reduction in Ambulatory Blood Pressure (ABP) Parameters
36 Month 24Hr Diastolic
|
62.4 mmHg
Standard Deviation NA
Cannot calculate standard deviation with one value
|
—
|
Adverse Events
Renal Denervation
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham Procedure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Renal Denervation
n=2 participants at risk
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
|
Sham Procedure
n=2 participants at risk
Sham procedure
Sham: Renal artery angiogram
Subjects exited after 1 month follow up
|
|---|---|---|
|
Vascular disorders
Subarachnoid Haemorrhage
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Renal and urinary disorders
Acute Renal Failure
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Gastrointestinal disorders
Bowel Obstruction
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Cardiac disorders
Chest pain
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
Other adverse events
| Measure |
Renal Denervation
n=2 participants at risk
Renal artery ablation with the EnligHTN™ Renal Denervation System.
EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
|
Sham Procedure
n=2 participants at risk
Sham procedure
Sham: Renal artery angiogram
Subjects exited after 1 month follow up
|
|---|---|---|
|
Renal and urinary disorders
Kidney/Flank Pain
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Renal and urinary disorders
Hematuria
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Gastrointestinal disorders
Hemorrhoids/Piles
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Vascular disorders
Other Vascular
|
50.0%
1/2 • Number of events 2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Renal and urinary disorders
Renal Cyst
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Reproductive system and breast disorders
Ovarian Cyst
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Renal and urinary disorders
Urinary Tract Infection
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Vascular disorders
Hypotension
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Infections and infestations
Bacterial infection
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Infections and infestations
Pneumonia
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
|
Cardiac disorders
Atrial flutter
|
50.0%
1/2 • Number of events 1 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
0.00%
0/2 • Ongoing through 3 years post procedure
All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place