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=99 Participants
|
60.4 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
57.2 years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Height
|
172.9 centimeters
STANDARD_DEVIATION 14.1 • n=99 Participants
|
171.5 centimeters
STANDARD_DEVIATION 5.4 • n=107 Participants
|
172.2 centimeters
STANDARD_DEVIATION 8.7 • n=206 Participants
|
|
Weight
|
81.0 kilograms
STANDARD_DEVIATION 18.4 • n=99 Participants
|
108.0 kilograms
STANDARD_DEVIATION 25.0 • n=107 Participants
|
94.5 kilograms
STANDARD_DEVIATION 23.7 • n=206 Participants
|
|
BMI
|
27.9 kg/m^2
STANDARD_DEVIATION 10.6 • n=99 Participants
|
36.5 kg/m^2
STANDARD_DEVIATION 6.2 • n=107 Participants
|
32.2 kg/m^2
STANDARD_DEVIATION 8.7 • n=206 Participants
|
|
Years with hypertension
|
30.5 years
STANDARD_DEVIATION 0.7 • n=99 Participants
|
36.0 years
STANDARD_DEVIATION 0 • n=107 Participants
|
32.3 years
STANDARD_DEVIATION 3.2 • n=206 Participants
|
|
Coronary Artery Disease
Yes
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Coronary Artery Disease
No
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Renal Artery Stenosis
Yes
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Renal Artery Stenosis
No
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Hyperlipidemia
Yes
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Hyperlipidemia
No
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Type II Diabetes
Yes
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Type II Diabetes
No
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Obstructive Sleep Apnea
Yes
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Obstructive Sleep Apnea
No
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
eGFR
|
91.0 mL/min/1.73 m2
STANDARD_DEVIATION 26.9 • n=99 Participants
|
71.5 mL/min/1.73 m2
STANDARD_DEVIATION 14.8 • n=107 Participants
|
81.3 mL/min/1.73 m2
STANDARD_DEVIATION 21.0 • n=206 Participants
|
|
Serum Creatinine
|
69.0 umol/L
STANDARD_DEVIATION 26.9 • n=99 Participants
|
83.0 umol/L
STANDARD_DEVIATION 1.4 • n=107 Participants
|
76.0 umol/L
STANDARD_DEVIATION 17.5 • n=206 Participants
|
|
Cystatin C
|
0.76 mg/L
STANDARD_DEVIATION 0.25 • n=99 Participants
|
0.98 mg/L
STANDARD_DEVIATION 0.18 • n=107 Participants
|
0.87 mg/L
STANDARD_DEVIATION 0.22 • n=206 Participants
|
|
Urine Albumin to Creatinine Ratio
|
10.5 mg/g
STANDARD_DEVIATION 2.1 • n=99 Participants
|
98.0 mg/g
STANDARD_DEVIATION 106.1 • n=107 Participants
|
54.3 mg/g
STANDARD_DEVIATION 79.4 • n=206 Participants
|
|
Office Systolic BP
|
178.0 mmHg
STANDARD_DEVIATION 17.0 • n=99 Participants
|
199.5 mmHg
STANDARD_DEVIATION 34.6 • n=107 Participants
|
188.8 mmHg
STANDARD_DEVIATION 25.5 • n=206 Participants
|
|
Office Diastolic BP
|
111.5 mmHg
STANDARD_DEVIATION 4.9 • n=99 Participants
|
88.0 mmHg
STANDARD_DEVIATION 1.4 • n=107 Participants
|
99.8 mmHg
STANDARD_DEVIATION 13.9 • n=206 Participants
|
|
Office Heart Rate
|
76.5 beats/minute
STANDARD_DEVIATION 12.0 • n=99 Participants
|
58.5 beats/minute
STANDARD_DEVIATION 7.8 • n=107 Participants
|
67.5 beats/minute
STANDARD_DEVIATION 13.3 • n=206 Participants
|
|
24-Hr Ambulatory Systolic BP
|
151.7 mmHg
STANDARD_DEVIATION 22.9 • n=99 Participants
|
155.3 mmHg
STANDARD_DEVIATION 4.3 • n=107 Participants
|
153.5 mmHg
STANDARD_DEVIATION 13.6 • n=206 Participants
|
|
24-Hr Ambulatory Diastolic BP
|
92.5 mmHg
STANDARD_DEVIATION 24.7 • n=99 Participants
|
75.4 mmHg
STANDARD_DEVIATION 1.4 • n=107 Participants
|
83.9 mmHg
STANDARD_DEVIATION 17.4 • n=206 Participants
|
|
24-Hr Ambulatory Heart Rate
|
68.2 beats/minute
STANDARD_DEVIATION 2.9 • n=99 Participants
|
60.5 beats/minute
STANDARD_DEVIATION 16.0 • n=107 Participants
|
64.3 beats/minute
STANDARD_DEVIATION 10.4 • n=206 Participants
|
|
Daytime Ambulatory Systolic BP
|
161.4 mmHg
STANDARD_DEVIATION 27.0 • n=99 Participants
|
155.0 mmHg
STANDARD_DEVIATION 2.7 • n=107 Participants
|
158.2 mmHg
STANDARD_DEVIATION 16.1 • n=206 Participants
|
|
Daytime Ambulatory Diastolic BP
|
99.8 mmHg
STANDARD_DEVIATION 27.6 • n=99 Participants
|
75.6 mmHg
STANDARD_DEVIATION 1.8 • n=107 Participants
|
87.7 mmHg
STANDARD_DEVIATION 21.2 • n=206 Participants
|
|
Daytime Ambulatory Heart Rate
|
69.4 beats/minute
STANDARD_DEVIATION 1.6 • n=99 Participants
|
60.6 beats/minute
STANDARD_DEVIATION 18.3 • n=107 Participants
|
65.0 beats/minute
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Number of Anti-hypertensive medications
|
4.0 number of anti-hypertensive medications
STANDARD_DEVIATION 1.4 • n=99 Participants
|
5.5 number of anti-hypertensive medications
STANDARD_DEVIATION 0.7 • n=107 Participants
|
4.8 number of anti-hypertensive medications
STANDARD_DEVIATION 1.3 • n=206 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
Vascular Access Site Complication
|
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
|
—
|
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