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)|
- Renal Denervation Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]Safety of Renal Denervation in patients with resistant hypertension as measured by Adverse Events [Time Frame: 1, 3, 6 months, annually up to 3 years]
- Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]Freedom from adverse renal events through 6 months post-procedure.
- Reduction [ Time Frame: 6 months ] [ Designated as safety issue: No ]Reduction of average office based measurements of systolic blood pressure between baseline and 6 months post-procedure.
- Ambulatory Blood Pressure Change [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]Change in 24 hour ambulatory blood pressure measurement (ABPM) from baseline to 3, 6 and 12 months post-procedure.
- Office Blood Pressure Change [ Time Frame: 5 years ] [ Designated as safety issue: No ]Change in office Systolic (SBP) and Diastolic Blood Pressure (DBP) from baseline to 1, 3, 12, 24, and 36 months post-procedure.
- Target Blood Pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]Incidence of subjects achieving target SBP (SBP <140 mmHg, or < 130 for patients with Type II diabetics) at 6 months.
- Blood Pressure Changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of changes in medical regimen for high blood pressure and low blood pressure through 6 months post-procedure.
Incidence of subjects achieving a ≥ 10 mmHg reduction in Systolic Office BP at 1 month, 3 months, 6 months and 12 months post procedure
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||December 2016|
|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|
|Na Homolce Hospital|
|Prague, Czech Republic, 15 030|
|Charles University Hospital|
|Prague, Czech Republic, 12808|
|Aarhus University Hospital, Skejby Sygehus|
|Aarhus, Denmark, 8200|
|Ospedale Generale Regionale|