A Prospective, Multi-Center, Non-Randomized Feasibility Study of Catheter-Based Renal Denervation to Treat Resistant Hypertension (RENABLATE- EC12-02)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypertension, Renal
- Sponsor
- Biosense Webster, Inc.
- Enrollment
- 35
- Primary Endpoint
- The Incidence of Major Cardiovascular and/or Renal Adverse Events Related to the Renal Denervation Procedure That Occurred Within 30 Days Post-procedure.
- Status
- Completed
- Last Updated
- last year
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is \> 18 and \< 85 years old.
- •Individual has a systolic blood pressure ≥ 160 mmHg (≥ 150 mmHg for type 2 diabetics) based on an average of 3 office blood pressure readings.
- •Individual is adhering to a stable drug regimen of at least 3 different classes of anti-hypertensive medications, including a diuretic (with no changes for a minimum of 2 weeks prior to enrollment) at optimal dose and is expected to be maintained for at least 6 months.
- •Individual agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.
Exclusion Criteria
- •Subjects with known/diagnosed secondary hypertension.
- •Subject has 'White Coat' hypertension defined as 24 hour daytime systolic blood pressure \<135 mm Hg as evaluated at Baseline visit.
- •Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational Celsius® ThermoCool® RD Multi-electrode Ablation Catheter.
- •Subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter.
- •Subject has multiple main renal arteries in either kidney.
- •Subject has a history of prior renal artery intervention including balloon angioplasty, stenting or surgery.
- •Subject had a previous kidney transplant or is a planned recipient of a transplant kidney or is on dialysis.
- •Subject has a past history of unilateral kidney removal or has a solitary functional kidney for any other reason.
- •Subject has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD formula.
- •Subject has type 1 diabetes mellitus.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Actual and Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure(From baseline to 1 ,3, 6 and 12 months post procedure)
- 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(From baseline to 3, 6 and 12 months post procedure)
- Incidence of Subjects Achieving at Least 10 mmHg Systolic Blood Pressure Reduction From Baseline at 1, 3, 6, and 12 Month Post-procedure(At 1, 3, 6, and 12 month post-procedure)
- Subjects Experienced Any Adverse Cardiovascular and Renal Events Through 12 Months Post-procedure(12 months post-procedure)
- Incidence of Subjects Achieving Target Systolic Blood Pressure at 1, 3, 6, and 12 Month Post-procedure(At 1, 3, 6, and 12 month post-procedure)