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:||Renal Denervation in Patients With Refractory Hypertension (RENABLATE- EC12-02)|
- Renal Denervation Safety [ Time Frame: 5 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 5 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.
- 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.
- 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, 36, 48 and 60 months.
- 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 2 diabetes mellitus) 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.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Experimental: Resistant Hypertension||Procedure: Renal Sympathetic Denervation Device: Celsius® ThermoCool® RD Multi-electrode Ablation Catheter|
|Contact: Liesbeth Vanderlinden||+32 2 7463527|
|Onze-Lieve-Vrouwziekenhuis Aalst||Not yet recruiting|
|Aalst, Belgium, 9300|
|Contact: An Roets +32 (0)3 205 9 305|
|Principal Investigator: E. Wyffels, MD|
|Na Homolce Hospital||Recruiting|
|Prague, Czech Republic, 15 030|
|Contact: Liz Coling +420 257 271 111|
|Principal Investigator: Petr Neuzil, MD|
|Aarhus University Hospital, Skejby Sygehus||Not yet recruiting|
|Aarhus, Denmark, 8200|
|Contact: Lars Jorgensen +45 784 56113|
|Principal Investigator: A. Kaltoft, MD|