Trial Outcomes & Findings for RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157 (NCT NCT02095691)

NCT ID: NCT02095691

Last Updated: 2025-02-04

Results Overview

Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 19 participants
• Primary outcome timeframe: 30 days post-procedure
• Results posted on: 2025-02-04

Participant Flow

The study enrollment took approximately 3 months, began on October 21, 2013 and completed on December 17, 2013. A total of 37 subjects were consented and 19 underwent treatment with the study catheter in 4 investigation sites in New Zealand, Czech Republic, and Italy.

Participant milestones

Measure	Renal Artery Sympathetic Denervation Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
Overall Study STARTED	19
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Renal Artery Sympathetic Denervation Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
Overall Study Physician Decision	1

Baseline Characteristics

RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157

Baseline characteristics by cohort

Measure	Renal Artery Sympathetic Denervation n=19 Participants Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
Age, Continuous	57.5 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized African Descent	1 participants n=5 Participants
Race/Ethnicity, Customized Not African Descent	18 participants n=5 Participants
Region of Enrollment New Zealand	6 participants n=5 Participants
Region of Enrollment Czech Republic	9 participants n=5 Participants
Region of Enrollment Italy	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-procedure

Population: The Safety Analysis population which consists of all enrolled subjects who have undergone insertion of the study ablation catheter.

Major adverse events include Acute myocardial infarction; Death from progressive heart failure, death from aortic or peripheral artery disease, from renal failure and sudden cardiac death; New-onset heart failure; Stroke; Aortic or lower limb revascularization procedure; Lower limb amputation; Beginning dialysis; Hospital admission for hypertensive emergency unrelated to non-adherence or non-persistence with drugs at each follow up visit; Hospitalization for atrial fibrillation.

Outcome measures

Measure	Renal Artery Sympathetic Denervation n=19 Participants Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.	Change in Blood Pressure at 3 Months Follow Up Change in Blood Pressure from baseline to3 months follow up	Change in Blood Pressure at 6 Months Follow Up Change in Blood Pressure from baseline to 6 months follow up	Change in Blood Pressure at 12 Month Follow Up Change in Blood Pressure from baseline to 12 months follow up
Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.	0.0 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 12 months post-procedure

Population: The safety analysis population consists of all enrolled subjects who have undergone insertion of the study ablation catheter.

These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural renal artery dissection or perforation requiring intervention, serious arterial access site related complications requiring intervention or prolonging hospitalization; ≥25% reduction between baseline and 12 months in renal function measured by the estimated Glomerular Filtration Rate (eGFR), as well as composite of major adverse cardiovascular and/or renal events.

Outcome measures

Measure	Renal Artery Sympathetic Denervation n=19 Participants Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.	Change in Blood Pressure at 3 Months Follow Up Change in Blood Pressure from baseline to3 months follow up	Change in Blood Pressure at 6 Months Follow Up Change in Blood Pressure from baseline to 6 months follow up	Change in Blood Pressure at 12 Month Follow Up Change in Blood Pressure from baseline to 12 months follow up
Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit	42.1 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: 12 months post-procedure

Population: Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.

Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.

Outcome measures

Measure	Renal Artery Sympathetic Denervation n=14 Participants Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.	Change in Blood Pressure at 3 Months Follow Up n=14 Participants Change in Blood Pressure from baseline to3 months follow up	Change in Blood Pressure at 6 Months Follow Up n=14 Participants Change in Blood Pressure from baseline to 6 months follow up	Change in Blood Pressure at 12 Month Follow Up n=13 Participants Change in Blood Pressure from baseline to 12 months follow up
Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure Mean Reduction in SBP	-16.4 mmHg Standard Deviation 18.3	-14.5 mmHg Standard Deviation 25.1	-11.3 mmHg Standard Deviation 24.4	-13.8 mmHg Standard Deviation 23.9
Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure Mean Reduction in DBP	-10.1 mmHg Standard Deviation 12.1	-5.2 mmHg Standard Deviation 11.7	-1.3 mmHg Standard Deviation 10.2	-4.9 mmHg Standard Deviation 10.3

SECONDARY outcome

Timeframe: 12 months post-procedure

Population: Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.

The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.

Outcome measures

Measure	Renal Artery Sympathetic Denervation n=14 Participants Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.	Change in Blood Pressure at 3 Months Follow Up n=14 Participants Change in Blood Pressure from baseline to3 months follow up	Change in Blood Pressure at 6 Months Follow Up n=14 Participants Change in Blood Pressure from baseline to 6 months follow up	Change in Blood Pressure at 12 Month Follow Up n=13 Participants Change in Blood Pressure from baseline to 12 months follow up
Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure	28.6 percentage of participants	7.1 percentage of participants	7.1 percentage of participants	7.1 percentage of participants

SECONDARY outcome

Timeframe: 12 months post-procedure

Population: Effectiveness analysis population, which consists of enrolled subjects without enrollment deviation and experiencing technical success. Technical success is defined as the investigational catheter being successfully inserted into the femoral artery with radiofrequency energy successfully applied in at least one artery.

Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months post procedure.

Outcome measures

Measure	Renal Artery Sympathetic Denervation n=14 Participants Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.	Change in Blood Pressure at 3 Months Follow Up n=14 Participants Change in Blood Pressure from baseline to3 months follow up	Change in Blood Pressure at 6 Months Follow Up n=14 Participants Change in Blood Pressure from baseline to 6 months follow up	Change in Blood Pressure at 12 Month Follow Up n=13 Participants Change in Blood Pressure from baseline to 12 months follow up
Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure	71.4 percentage of participants	50 percentage of participants	50 percentage of participants	53.8 percentage of participants

Adverse Events

Renal Artery Sympathetic Denervation

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Renal Artery Sympathetic Denervation n=19 participants at risk Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
Vascular disorders Arterial spasm	5.3% 1/19 • Number of events 1 • 12 Months
Cardiac disorders Atrial fibrillation	5.3% 1/19 • Number of events 1 • 12 Months
Musculoskeletal and connective tissue disorders Back Pain	5.3% 1/19 • Number of events 1 • 12 Months
Metabolism and nutrition disorders Gout	5.3% 1/19 • Number of events 1 • 12 Months
Vascular disorders Hypertension	5.3% 1/19 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Joint Sprain	5.3% 1/19 • Number of events 1 • 12 Months
Renal and urinary disorders Renal artery stenosis	10.5% 2/19 • Number of events 2 • 12 Months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cyst	5.3% 1/19 • Number of events 1 • 12 Months
Renal and urinary disorders Renal Mass	5.3% 1/19 • Number of events 1 • 12 Months
Injury, poisoning and procedural complications Pseudoaneurysm	5.3% 1/19 • Number of events 1 • 12 Months
Vascular disorders Hypotension	15.8% 3/19 • Number of events 4 • 12 Months

Additional Information

Liesbeth Vanderlinden, Manager Clinical Research

Biosense Webster, EMEA

Phone: +32(0)2 7463527

Email: lvanderl@its.JNJ.com

Results disclosure agreements

• Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.
• Publication restrictions are in place

Restriction type: OTHER