RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension
|ClinicalTrials.gov Identifier: NCT01756300|
Recruitment Status : Completed
First Posted : December 25, 2012
Results First Posted : August 25, 2015
Last Update Posted : November 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypertension, Renal||Device: Celsius® ThermoCool® RD||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi‐Center, Non‐Randomized Feasibility Study of Catheter‐Based Renal Denervation to Treat Resistant Hypertension (RENABLATE- EC12-02)|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||November 2013|
|Actual Study Completion Date :||April 2015|
Experimental: Resistant Hypertension
The catheter-based (device: Celsius® ThermoCool® RD) renal denervation will serve to treat resistant hypertension.
Device: Celsius® ThermoCool® RD
The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation.
Other Name: Multi-electrode Ablation Catheter
- The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure. [ Time Frame: 30 days post-procedure ]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.
- Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure [ Time Frame: 12 months post-procedure ]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.
- Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure [ Time Frame: From baseline to 1 ,3, 6 and 12 months post procedure ]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.
- 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 [ Time Frame: From baseline to 3, 6 and 12 months post procedure ]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.
- Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure [ Time Frame: At 1, 3, 6, and 12 month post-procedure ]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).
- Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure [ Time Frame: At 1, 3, 6, and 12 month post-procedure ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756300
|Peninsula Heart Centre|
|Frankston, Victoria, Australia, 3199|
|Aalst, Belgium, 9300|
|Genk, Belgium, 3600|
|Charles University Hospital|
|Prague, Czech Republic, 12808|
|Na Homolce Hospital|
|Prague, Czech Republic, 15 030|
|Aarhus University Hospital, Skejby Sygehus|
|Aarhus, Denmark, 8200|
|Ospedale Generale Regionale|