Clinical Trial: RENABLATE-II Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension - 157

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-II - 157)

Brief Summary: This is a prospective, multi-center, non-randomized, feasibility study to assess the safety and effectiveness of renal artery sympathetic denervation using the investigational devices in subjects with resistant hypertension.

Detailed Summary:
Sponsor: Biosense Webster, Inc.

Current Primary Outcome: Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure. [ Time Frame: 30 days post-procedure ]

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: 3 years ]

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]


Current Secondary Outcome:

  • Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit [ Time Frame: 12 months post-procedure ]
    These adverse events include renal artery stenosis (≥60% diameter reduction confirmed by MRI or renal angiography); peri-procedural 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.
  • Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure [ Time Frame: 12 months post-procedure ]
    Office systolic blood pressure (SBP) and diastolic blood pressure (DBP) measures were summarized to assess the reduction in blood pressure from baseline visit to post baseline at 1, 3, 6, and 12 months. Negative values for change represent reductions.
  • Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure [ Time Frame: 12 months post-procedure ]
    The pre-specified target SBP is defined as SBP <130 mmHg. This endpoint is defined at each of 1, 3, 6 and 12 months post procedure.
  • Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure [ Time Frame: 12 months post-procedure ]
    Incidence of subjects achieving a 10 mmHg or more reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 months 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 post-procedure.
  • Office Blood Pressure Change [ Time Frame: 3 years ]
    Change in office Systolic (SBP) and Diastolic Blood Pressure (DBP) from baseline to 1, 3, 12 months post-procedure.
  • Target Blood Pressure [ Time Frame: 6 months ]
    Incidence of subjects achieving target SBP (<130 mmHg) 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 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



Information By: Biosense Webster, Inc.

Dates:
Date Received: March 21, 2014
Date Started: October 2013
Date Completion:
Last Updated: October 30, 2015
Last Verified: October 2015