Trial Outcomes & Findings for RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (NCT NCT01756300)

Last Updated: 2025-02-04

Results Overview

The 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

35 participants

Primary outcome timeframe

30 days post-procedure

Results posted on

2025-02-04

Participant Flow

The study enrollment took approximately 11 months, began in December 2, 2012 and completed on November 4, 2013. A total of 68 subjects were consented and 35 started the renal denervation with the investigational ablation catheter.

After signing the inform of consent, subjects were evaluated on inclusion/exclusion criteria, anatomic eligibility, compliant with completing the subject diary. Thirty-three subjects failed and never underwent insertion of the study ablation catheter.

Participant milestones

Participant milestones
Measure	Renal Sympathetic Denervation Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with severe resistant hypertension.
Overall Study STARTED	35
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Renal Sympathetic Denervation Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with severe resistant hypertension.
Overall Study Death	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Renal Sympathetic Denervation n=35 Participants Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
Age, Continuous	62.5 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race/Ethnicity, Customized African Descent	0 participants n=5 Participants
Race/Ethnicity, Customized Not African Descent	35 participants n=5 Participants
Region of Enrollment Czech Republic	12 participants n=5 Participants
Region of Enrollment Belgium	5 participants n=5 Participants
Region of Enrollment Denmark	1 participants n=5 Participants
Region of Enrollment Australia	15 participants n=5 Participants
Region of Enrollment Italy	2 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.

Outcome measures

Outcome measures
Measure	Renal Sympathetic Denervation n=35 Participants Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.	Blood Pressures at 1-Month Follow Up Office blood pressures measured at one month post-procedure	Blood Pressures at 3-Month Follow Up Office blood pressures measured at 3-month post procedure	Blood Pressures at 6-Month Follow Up Office blood pressures measured at 6-month post procedure	Blood Pressures at 12-Month Follow Up Office blood pressures measured at 12-month post procedure
The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.	0.0 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 12 months post-procedure

Population: The Safety Analysis population, which 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); periprocedural 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

Outcome measures
Measure	Renal Sympathetic Denervation n=35 Participants Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.	Blood Pressures at 1-Month Follow Up Office blood pressures measured at one month post-procedure	Blood Pressures at 3-Month Follow Up Office blood pressures measured at 3-month post procedure	Blood Pressures at 6-Month Follow Up Office blood pressures measured at 6-month post procedure	Blood Pressures at 12-Month Follow Up Office blood pressures measured at 12-month post procedure
Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure	74.3 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: From baseline to 1 ,3, 6 and 12 months post procedure

Population: The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and radiofrequency (RF) energy is successfully applied in at least one artery. .

This secondary effectiveness endpoint is defined as actual and change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure. Negative values represent reduction from baseline.

Outcome measures

Outcome measures
Measure	Renal Sympathetic Denervation n=27 Participants Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.	Blood Pressures at 1-Month Follow Up n=27 Participants Office blood pressures measured at one month post-procedure	Blood Pressures at 3-Month Follow Up n=27 Participants Office blood pressures measured at 3-month post procedure	Blood Pressures at 6-Month Follow Up n=26 Participants Office blood pressures measured at 6-month post procedure	Blood Pressures at 12-Month Follow Up n=26 Participants Office blood pressures measured at 12-month post procedure
Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure Systolic Office Blood Pressure	171.0 mmHg Standard Deviation 10.4	161.0 mmHg Standard Deviation 21.1	159.7 mmHg Standard Deviation 21.7	155.4 mmHg Standard Deviation 15.6	151.0 mmHg Standard Deviation 18.7
Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure Systolic Mean Change from Baseline	NA mmHg Standard Deviation NA Not applicable at Baseline for change from Baseline measures	-10.0 mmHg Standard Deviation 21.1	-11.3 mmHg Standard Deviation 21.9	-15.4 mmHg Standard Deviation 17.6	-19.8 mmHg Standard Deviation 20.7
Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure Diastolic Office Blood Pressure	95.8 mmHg Standard Deviation 16.3	88.3 mmHg Standard Deviation 15.0	87.5 mmHg Standard Deviation 13	85.0 mmHg Standard Deviation 11.7	86.4 mmHg Standard Deviation 15.7
Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure Diastolic Mean Change from Baseline	NA mmHg Standard Deviation NA Not applicable at Baseline for change from Baseline measures	-7.6 mmHg Standard Deviation 13.7	-8.3 mmHg Standard Deviation 12.4	-10.7 mmHg Standard Deviation 13.5	-9.0 mmHg Standard Deviation 12.9

SECONDARY outcome

Timeframe: From baseline to 3, 6 and 12 months post procedure

Population: The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .

This secondary effectiveness endpoint is defined as change in 24-hour ABPM systolic blood pressure and diastolic blood pressure from baseline to 3, 6 and 12 months post procedure. The blood pressures were measured using the 24-hour Ambulatory Blood Pressure Monitoring system. Reported values are the arithmetic mean of collected blood pressure values over 24 hours. Negative values represent reduction from baseline.

Outcome measures

Outcome measures
Measure	Renal Sympathetic Denervation n=27 Participants Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.	Blood Pressures at 1-Month Follow Up n=26 Participants Office blood pressures measured at one month post-procedure	Blood Pressures at 3-Month Follow Up n=26 Participants Office blood pressures measured at 3-month post procedure	Blood Pressures at 6-Month Follow Up n=26 Participants Office blood pressures measured at 6-month post procedure	Blood Pressures at 12-Month Follow Up Office blood pressures measured at 12-month post procedure
Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure Diastolic Mean Change from Baseline	NA mmHg Standard Deviation NA Not applicable at Baseline for change from Baseline measures	-3.9 mmHg Standard Deviation 8.2	-6.8 mmHg Standard Deviation 8.0	-7.1 mmHg Standard Deviation 6.7	—
Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure Systolic Office Blood Pressure	156.0 mmHg Standard Deviation 12.9	145.4 mmHg Standard Deviation 17.2	142.1 mmHg Standard Deviation 15.6	141.2 mmHg Standard Deviation 15.6	—
Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure Systolic Mean Change from Baseline	NA mmHg Standard Deviation NA Not applicable at Baseline for change from Baseline measures	-9.8 mmHg Standard Deviation 12.7	-13.1 mmHg Standard Deviation 15.7	-14.7 mmHg Standard Deviation 14.9	—
Actual and Change in 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 3, 6 and 12 Months Post Procedure Diastolic Office Blood Pressure	85.8 mmHg Standard Deviation 12.7	80.8 mmHg Standard Deviation 10.8	78.5 mmHg Standard Deviation 11.9	79.0 mmHg Standard Deviation 11.2	—

SECONDARY outcome

Timeframe: At 1, 3, 6, and 12 month post-procedure

Population: The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .

This endpoint is defined as incidence of subjects achieving target systolic blood pressure at 1, 3, 6, and 12 month post-procedure. Target systolic blood pressure is defined as less than 140 mmHg (and less than 130 mmHg for Type II Diabetics).

Outcome measures

Outcome measures
Measure	Renal Sympathetic Denervation n=27 Participants Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.	Blood Pressures at 1-Month Follow Up n=27 Participants Office blood pressures measured at one month post-procedure	Blood Pressures at 3-Month Follow Up n=26 Participants Office blood pressures measured at 3-month post procedure	Blood Pressures at 6-Month Follow Up n=26 Participants Office blood pressures measured at 6-month post procedure	Blood Pressures at 12-Month Follow Up Office blood pressures measured at 12-month post procedure
Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure	14.8 percentage of participants	18.5 percentage of participants	15.4 percentage of participants	23.1 percentage of participants	—

SECONDARY outcome

Timeframe: At 1, 3, 6, and 12 month post-procedure

Population: The Effectiveness analysis population, which consists of all enrolled subjects who have had technical success without major protocol deviations. Technical Success is defined to be when the investigational catheter has been successfully inserted into the femoral artery and RF energy is successfully applied in at least one artery. .

This endpoint is defined as Incidence of subjects achieving at least 10 mmHg systolic blood pressure reduction from Baseline at 1, 3, 6, and 12 month post-procedure

Outcome measures

Outcome measures
Measure	Renal Sympathetic Denervation n=27 Participants Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.	Blood Pressures at 1-Month Follow Up n=27 Participants Office blood pressures measured at one month post-procedure	Blood Pressures at 3-Month Follow Up n=26 Participants Office blood pressures measured at 3-month post procedure	Blood Pressures at 6-Month Follow Up n=26 Participants Office blood pressures measured at 6-month post procedure	Blood Pressures at 12-Month Follow Up Office blood pressures measured at 12-month post procedure
Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure	48.1 percentage of participants	48.1 percentage of participants	61.5 percentage of participants	76.9 percentage of participants	—

Adverse Events

Renal Sympathetic Denervation

Serious events: 7 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Renal Sympathetic Denervation n=35 participants at risk Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Cardiac disorders Atrial fibrillation	5.7% 2/35 • Number of events 2 • Twelve months post procedure
Gastrointestinal disorders Gastritis	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Vascular disorders Hypertension	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Musculoskeletal and connective tissue disorders Lumbar pain	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Renal and urinary disorders Renal artery stenosis	5.7% 2/35 • Number of events 2 • Twelve months post procedure
General disorders Sudden death	2.9% 1/35 • Number of events 1 • Twelve months post procedure

Other adverse events

Other adverse events
Measure	Renal Sympathetic Denervation n=35 participants at risk Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
Investigations Albumin urine high	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Cardiac disorders Atrial fibrillation	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Cardiac disorders Bradycardia	8.6% 3/35 • Number of events 3 • Twelve months post procedure
Respiratory, thoracic and mediastinal disorders Breathlessness	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Infections and infestations Bronchopneumonia	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Nervous system disorders Dizziness	2.9% 1/35 • Number of events 1 • Twelve months post procedure
General disorders Flu-like illness	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Renal and urinary disorders Function kidney decreased	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Vascular disorders Hypertension	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Vascular disorders Hypertension worsened	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Vascular disorders Hypertensive crisis	5.7% 2/35 • Number of events 2 • Twelve months post procedure
Metabolism and nutrition disorders Hypokalaemia	5.7% 2/35 • Number of events 2 • Twelve months post procedure
Vascular disorders Hypotension	8.6% 3/35 • Number of events 3 • Twelve months post procedure
Injury, poisoning and procedural complications Incision site bleeding	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Injury, poisoning and procedural complications Incision site hematoma	8.6% 3/35 • Number of events 3 • Twelve months post procedure
General disorders Inflammation	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Musculoskeletal and connective tissue disorders Lumbar pain	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Infections and infestations Middle ear infection	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Nervous system disorders Numbness	2.9% 1/35 • Number of events 1 • Twelve months post procedure
General disorders Oedema	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Musculoskeletal and connective tissue disorders Painful knee	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Cardiac disorders Palpitations	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Investigations Raised blood pressure	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Renal and urinary disorders Renal artery stenosis	8.6% 3/35 • Number of events 3 • Twelve months post procedure
Investigations Renal function test	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Investigations Serum potassium decreased	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Investigations Serum sodium decreased	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Musculoskeletal and connective tissue disorders Shoulder pain	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Vascular disorders Spasm of artery	11.4% 4/35 • Number of events 4 • Twelve months post procedure
Cardiac disorders Supraventricular tachycardia	2.9% 1/35 • Number of events 1 • Twelve months post procedure
General disorders Swelling arm	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Nervous system disorders Syncope	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Renal and urinary disorders Urethral irritation	2.9% 1/35 • Number of events 1 • Twelve months post procedure
Nervous system disorders Vertebral artery stenosis	2.9% 1/35 • Number of events 1 • Twelve months post procedure

Additional Information

Liesbeth Vanderlinden, Manager Clinical Research

Biosense Webster, EMEA

Phone: +32(0)2 7463527

Email: [email protected]

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