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Trial record 1 of 1 for:    EnligHTN IV
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EnligHTN IV Trial - Multicenter Sham-controlled RCT of Renal Denervation for Hypertension (EnligHTN-IV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01903187
Recruitment Status : Terminated (There were no safety or effectiveness concerns. There were concerns about completing enrollment due to a competitive device's potential approval.)
First Posted : July 19, 2013
Results First Posted : March 17, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Hypertension
Interventions Device: EnligHTN Renal Denervation
Procedure: Sham
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description

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: Renal artery angiogram

Period Title: Procedure
Started 2 2
Completed 2 2
Not Completed 0 0
Period Title: 1 Month
Started 2 2
Completed 2 2
Not Completed 0 0
Period Title: 3 Month
Started 2 0
Completed 2 0
Not Completed 0 0
Period Title: 6 Month
Started 2 0
Completed 2 0
Not Completed 0 0
Period Title: 12 Month
Started 2 0
Completed 2 0
Not Completed 0 0
Arm/Group Title Renal Denervation Sham Procedure Total
Hide Arm/Group Description

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: Renal artery angiogram

Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
All subjects enrolled.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
54.1  (8.9) 60.4  (6.7) 57.2  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
2
 100.0%
1
  50.0%
3
  75.0%
Male
0
   0.0%
1
  50.0%
1
  25.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
 100.0%
2
 100.0%
4
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  50.0%
0
   0.0%
1
  25.0%
White
1
  50.0%
2
 100.0%
3
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 2 participants 2 participants 4 participants
172.9  (14.1) 171.5  (5.4) 172.2  (8.7)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 2 participants 2 participants 4 participants
81.0  (18.4) 108.0  (25.0) 94.5  (23.7)
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 2 participants 2 participants 4 participants
27.9  (10.6) 36.5  (6.2) 32.2  (8.7)
[1]
Measure Description: Body mass index
Years with hypertension  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
30.5  (0.7) 36.0  (0) 32.3  (3.2)
Coronary Artery Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Yes 1 0 1
No 1 2 3
Renal Artery Stenosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Yes 0 0 0
No 2 2 4
Hyperlipidemia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Yes 1 2 3
No 1 0 1
Type II Diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Yes 0 0 0
No 2 2 4
Obstructive Sleep Apnea  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Yes 0 1 1
No 2 1 3
eGFR   [1] 
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73 m2
Number Analyzed 2 participants 2 participants 4 participants
91.0  (26.9) 71.5  (14.8) 81.3  (21.0)
[1]
Measure Description:

Estimated glomular filtration rate use Modified Diet in Renal Disease formula:

For creatinine in µmol/L:

eGFR = 32788 X Serum Creatinine^-1.154 X Age^-0.203 X [1.210 if Black] X [0.742 if Female]

Serum Creatinine  
Mean (Standard Deviation)
Unit of measure:  umol/L
Number Analyzed 2 participants 2 participants 4 participants
69.0  (26.9) 83.0  (1.4) 76.0  (17.5)
Cystatin C  
Mean (Standard Deviation)
Unit of measure:  mg/L
Number Analyzed 2 participants 2 participants 4 participants
0.76  (0.25) 0.98  (0.18) 0.87  (0.22)
Urine Albumin to Creatinine Ratio   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/g
Number Analyzed 2 participants 2 participants 4 participants
10.5  (2.1) 98.0  (106.1) 54.3  (79.4)
[1]
Measure Description: Ratio reported as milligrams of albumin per gram of creatinine.
Office Systolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 2 participants 2 participants 4 participants
178.0  (17.0) 199.5  (34.6) 188.8  (25.5)
Office Diastolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 2 participants 2 participants 4 participants
111.5  (4.9) 88.0  (1.4) 99.8  (13.9)
Office Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Beats/minute
Number Analyzed 2 participants 2 participants 4 participants
76.5  (12.0) 58.5  (7.8) 67.5  (13.3)
24-Hr Ambulatory Systolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 2 participants 2 participants 4 participants
151.7  (22.9) 155.3  (4.3) 153.5  (13.6)
24-Hr Ambulatory Diastolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 2 participants 2 participants 4 participants
92.5  (24.7) 75.4  (1.4) 83.9  (17.4)
24-Hr Ambulatory Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Beats/minute
Number Analyzed 2 participants 2 participants 4 participants
68.2  (2.9) 60.5  (16.0) 64.3  (10.4)
Daytime Ambulatory Systolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 2 participants 2 participants 4 participants
161.4  (27.0) 155.0  (2.7) 158.2  (16.1)
Daytime Ambulatory Diastolic BP  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 2 participants 2 participants 4 participants
99.8  (27.6) 75.6  (1.8) 87.7  (21.2)
Daytime Ambulatory Heart Rate  
Mean (Standard Deviation)
Unit of measure:  Beats/minute
Number Analyzed 2 participants 2 participants 4 participants
69.4  (1.6) 60.6  (18.3) 65.0  (11.7)
Number of Anti-hypertensive medications  
Mean (Standard Deviation)
Unit of measure:  Number of anti-hypertensive medications
Number Analyzed 2 participants 2 participants 4 participants
4.0  (1.4) 5.5  (0.7) 4.8  (1.3)
1.Primary Outcome
Title 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).
Hide Description 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.
Time Frame 6 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects randomized to the EnligHTN procedure
Arm/Group Title Renal Denervation
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of participants
Proportion of Subjects with MAE 0
Proportion Subjects without MAE 100
2.Primary Outcome
Title The Primary Effectiveness Endpoint is the Reduction of Office Systolic Blood Pressure (OSBP) at Six (6) Months Post Randomization Compared to Baseline Between Groups
Hide Description [Not Specified]
Time Frame 6 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description:

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: Renal artery angiogram

Overall Number of Participants Analyzed 2 0
Mean (Standard Deviation)
Unit of Measure: mmHg
-22.5  (36)
3.Secondary Outcome
Title Device or Procedure Related Adverse Events by Severity Post Randomization Through Six (6) Months
Hide Description 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.
Time Frame 6 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received renal denervation
Arm/Group Title Renal Denervation
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
4.Secondary Outcome
Title The Number of Subjects That Experience Each Type of MAE
Hide Description 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.
Time Frame 6 months post randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received renal denervation
Arm/Group Title Renal Denervation
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
All Cause Mortality
0
   0.0%
End Stage Renal Disease (eGFR <15ml/min/m2)
0
   0.0%
Significant Embolic Event
0
   0.0%
Renal Artery Perforation
0
   0.0%
Renal Artery Dissection
0
   0.0%
Vascular Access Site Complication
0
   0.0%
Hypertensive Crisis
0
   0.0%
Renal Artery Stenosis
0
   0.0%
5.Secondary Outcome
Title Incidence of Achieving ≥ 10 mmHg, ≥ 15 mmHg, and ≥20 mmHg Reductions in OSBP
Hide Description 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.
Time Frame 6 months post randomization, and all follow-up timepoints
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received renal denervation
Arm/Group Title Renal Denervation
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
Responders ≥10mmHg SBP reduction from BL(6M) Number Analyzed 2 participants
1
  50.0%
Responders ≥10mmHg SBP reduction from BL(12M) Number Analyzed 2 participants
1
  50.0%
Responders ≥10mmHg SBP reduction from BL(18M) Number Analyzed 2 participants
1
  50.0%
Responders ≥10mmHg SBP reduction from BL(24M) Number Analyzed 1 participants
1
 100.0%
Responders ≥10mmHg SBP reduction from BL(30M) Number Analyzed 1 participants
1
 100.0%
Responders ≥10mmHg SBP reduction from BL(36M) Number Analyzed 1 participants
1
 100.0%
Responders ≥15mmHg SBP reduction from BL (6M) Number Analyzed 2 participants
1
  50.0%
Responders ≥15mmHg SBP reduction from BL (12M) Number Analyzed 2 participants
1
  50.0%
Responders ≥15mmHg SBP reduction from BL (18M) Number Analyzed 2 participants
1
  50.0%
Responders ≥15mmHg SBP reduction from BL (24M) Number Analyzed 1 participants
1
 100.0%
Responders ≥15mmHg SBP reduction from BL (30M) Number Analyzed 1 participants
1
 100.0%
Responders ≥15mmHg SBP reduction from BL (36M) Number Analyzed 1 participants
1
 100.0%
Responders ≥20mmHg SBP reduction from BL (6M) Number Analyzed 2 participants
1
  50.0%
Responders ≥20mmHg SBP reduction from BL (12M) Number Analyzed 2 participants
1
  50.0%
Responders ≥20mmHg SBP reduction from BL (18M) Number Analyzed 2 participants
1
  50.0%
Responders ≥20mmHg SBP reduction from BL (24M) Number Analyzed 1 participants
1
 100.0%
Responders ≥20mmHg SBP reduction from BL (30M) Number Analyzed 1 participants
1
 100.0%
Responders ≥20mmHg SBP reduction from BL (36M) Number Analyzed 1 participants
1
 100.0%
6.Secondary Outcome
Title Reduction in Ambulatory Blood Pressure (ABP) Parameters
Hide Description 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.
Time Frame baseline, 6 months post randomization, and all follow-up timepoints
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects
Arm/Group Title Renal Denervation Sham
Hide Arm/Group Description:

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

Renal artery angiogram without renal denervation
Overall Number of Participants Analyzed 2 2
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 24Hr Systolic Number Analyzed 2 participants 2 participants
151.7  (22.9) 155.3  (4.3)
1 Month 24Hr Systolic Number Analyzed 2 participants 2 participants
128.8  (1.3) 155.5  (6.8)
3 Month 24Hr Systolic Number Analyzed 2 participants 0 participants
158.9  (50.8)
6 Month 24Hr Systolic Number Analyzed 1 participants 0 participants
124.7 [1]   (NA)
12 Month 24Hr Systolic Number Analyzed 1 participants 0 participants
121.3 [1]   (NA)
18 Month 24Hr Systolic Number Analyzed 1 participants 0 participants
133.6 [1]   (NA)
24 Month 24Hr Systolic Number Analyzed 1 participants 0 participants
123.1 [1]   (NA)
30 Month 24Hr Systolic Number Analyzed 1 participants 0 participants
123.2 [1]   (NA)
36 Month 24Hr Systolic Number Analyzed 1 participants 0 participants
121.5 [1]   (NA)
Baseline 24Hr Diastolic Number Analyzed 2 participants 2 participants
92.5  (24.7) 75.4  (1.4)
1 Month 24Hr Diastolic Number Analyzed 2 participants 2 participants
78.8  (13.5) 73.9  (4.9)
3 Month 24Hr Diastolic Number Analyzed 2 participants 0 participants
93.9  (37.8)
6 Month 24Hr Diastolic Number Analyzed 2 participants 0 participants
66.2 [1]   (NA)
12 Month 24Hr Diastolic Number Analyzed 2 participants 0 participants
67.3 [1]   (NA)
18 Month 24Hr Diastolic Number Analyzed 2 participants 0 participants
71.7 [1]   (NA)
24 Month 24Hr Diastolic Number Analyzed 2 participants 0 participants
65.2 [1]   (NA)
30 Month 24Hr Diastolic Number Analyzed 2 participants 0 participants
61.3 [1]   (NA)
36 Month 24Hr Diastolic Number Analyzed 2 participants 0 participants
62.4 [1]   (NA)
[1]
Cannot calculate standard deviation with one value
Time Frame Ongoing through 3 years post procedure
Adverse Event Reporting Description All events were adjudicated by an independent Clinical Events Committee. Current events included through last annual report (April 2015)
 
Arm/Group Title Renal Denervation Sham Procedure
Hide Arm/Group Description

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: Renal artery angiogram

Subjects exited after 1 month follow up

All-Cause Mortality
Renal Denervation Sham Procedure
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
Renal Denervation Sham Procedure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      0/2 (0.00%)    
Cardiac disorders     
Chest pain *  1/2 (50.00%)  1 0/2 (0.00%)  0
Gastrointestinal disorders     
Bowel Obstruction *  1/2 (50.00%)  1 0/2 (0.00%)  0
Renal and urinary disorders     
Acute Renal Failure *  1/2 (50.00%)  1 0/2 (0.00%)  0
Vascular disorders     
Subarachnoid Haemorrhage *  1/2 (50.00%)  1 0/2 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Renal Denervation Sham Procedure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      0/2 (0.00%)    
Cardiac disorders     
Atrial flutter *  1/2 (50.00%)  1 0/2 (0.00%)  0
Gastrointestinal disorders     
Hemorrhoids/Piles *  1/2 (50.00%)  1 0/2 (0.00%)  0
Infections and infestations     
Bacterial infection *  1/2 (50.00%)  1 0/2 (0.00%)  0
Pneumonia *  1/2 (50.00%)  1 0/2 (0.00%)  0
Renal and urinary disorders     
Kidney/Flank Pain *  1/2 (50.00%)  1 0/2 (0.00%)  0
Hematuria *  1/2 (50.00%)  1 0/2 (0.00%)  0
Renal Cyst *  1/2 (50.00%)  1 0/2 (0.00%)  0
Urinary Tract Infection *  1/2 (50.00%)  1 0/2 (0.00%)  0
Reproductive system and breast disorders     
Ovarian Cyst *  1/2 (50.00%)  1 0/2 (0.00%)  0
Vascular disorders     
Other Vascular * [1]  1/2 (50.00%)  2 0/2 (0.00%)  0
Hypotension *  1/2 (50.00%)  1 0/2 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
findings of non-significant plaque or calcium in arteries - unrelated per independent CEC
Enrollment ended early due to a sponsor decision unrelated to safety. The 2 treatment group subjects are being followed up through 3 years. The 2 sham group subjects were exited after their 1 month visit. Due to these reasons, data is limited.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Madej
Organization: St. Jude Medical, Inc.
Phone: 651-756-2230
EMail: smadej@sjm.com
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01903187    
Other Study ID Numbers: 1204
First Submitted: July 9, 2013
First Posted: July 19, 2013
Results First Submitted: October 15, 2015
Results First Posted: March 17, 2016
Last Update Posted: February 15, 2019