RENABLATE Feasibility - EC12-02
The RENABLATE study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter and integrated ablation system to treat resistant hypertension.
Procedure: Renal Sympathetic Denervation
Device: Celsius® ThermoCool® RD Multi-electrode Ablation Catheter
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Multi-center, Non Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE- EC12-02)|
- 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
- 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 12 months post-procedure ] [ Designated as safety issue: No ]This secondary effectiveness endpoint is defined as Change in office systolic blood pressure and diastolic blood pressure from baseline to 1 ,3, 6 and 12 months post procedure
- 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 12 months post-procedure ] [ Designated as safety issue: No ]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.
- Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure [ Time Frame: 12 months post-procedure ] [ Designated as safety issue: No ]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: 12 months post-procedure ] [ Designated as safety issue: No ]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
|Study Start Date:||December 2012|
|Study Completion Date:||April 2015|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
|Experimental: Resistant Hypertension||Procedure: Renal Sympathetic Denervation Device: Celsius® ThermoCool® RD Multi-electrode Ablation Catheter|
Please refer to this study by its ClinicalTrials.gov identifier: 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|