A Prospective, Multi-center, Non-Randomized, Feasibility Study of Catheter Based Renal Denervation to Treat Resistant Hypertension (RENABLATE-II - 157)

Biosense Webster, Inc.0 sites19 target enrollmentOctober 2013

ConditionsHypertension, Renal

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hypertension, Renal
Sponsor: Biosense Webster, Inc.
Enrollment: 19
Primary Endpoint: Incidence of Major Adverse Events That Occurred Within 30 Days Post-procedure.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

April 2015

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biosense Webster, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has a systolic blood pressure ≥ 140 mmHg based on an average of 3 office blood pressure readings measured according to the BP guidelines.
•Subject 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.
•Subject is \> 18 and \< 85 years of age.
•Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study.

Exclusion Criteria

•A secondary cause of hypertension, e.g. "white coat" hypertension (assessed by 24 h ABPM at physician's discretion), primary aldosteronism, pheochromocytoma, renal artery stenosis, drug induced-hypertension, Adult Polycystic kidney Disease, renal cell carcinoma, pyelonephritis, glomerulonephritis, coarctation of the aorta, acromegaly, Cushing's Syndrome, Conn's (primary hyperaldosteronism), polyarteritis nodosum, systemic sclerosis, parenchymal kidney disease, obstructive sleep apnoea based on a workup performed within the 12 months preceding enrollment.
•Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s).
•Subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter.
•Subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery.
•Subject has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD formula.
•Subject has type 1 diabetes mellitus.
•Subject has history of Myocardial Infarction, unstable angina pectoris, or a cerebrovascular accident in the 6 months period prior to enrolment, or documented widespread atherosclerosis, intravascular thrombosis or unstable plaques.
•Subject has hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Incidence of Subjects Achieving a ≥ 10 mmHg Reduction in Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure(12 months post-procedure)
Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit(12 months post-procedure)
Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 12 Months Post Procedure(12 months post-procedure)
Mean Change in Office Systolic Blood Pressure and Diastolic Blood Pressure From Baseline to 1 ,3, 6 and 12 Months Post Procedure(12 months post-procedure)