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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Multi‐Center, Non‐Randomized Feasibility Study of Catheter‐Based Renal Denervation to Treat Resistant Hypertension (RENABLATE- EC12-02)

Brief Summary: The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of the investigational multi-electrode ablation catheter and integrated ablation system to treat resistant hypertension.

Detailed Summary: The RENABLATE feasibility study CS156 (EC12-02) is a prospective, multi-center, non-randomized feasibility study to evaluate the safety and effectiveness of renal artery sympathetic denervation using the investigational Celsius® ThermoCool® Renal Denervation (RD) Multi-electrode Ablation Catheter and integrated ablation system to treat resistant hypertension.
Sponsor: Biosense Webster, Inc.

Current Primary Outcome: 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.


Original Primary Outcome: Renal Denervation Safety [ Time Frame: 5 years ]

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]


Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • Safety [ Time Frame: 6 months ]
    Freedom from adverse renal events through 6 months post-procedure.
  • Reduction [ Time Frame: 6 months ]
    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 ]
    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 ]
    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 ]
    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 ]
    Incidence of changes in medical regimen for high blood pressure and low blood pressure through 6 months.


Information By: Biosense Webster, Inc.

Dates:
Date Received: December 20, 2012
Date Started: December 2012
Date Completion:
Last Updated: October 15, 2015
Last Verified: October 2015