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

Phase 1CompletedNCT02095691

Biosense Webster, Inc.19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension, Renal

Interventions

Celsius® ThermoCool® Renal DenervationDEVICE

The investigational device is indicated for the treatment of resistant hypertension by renal denervation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject has a systolic blood pressure ≥ 140 mmHg based on an average of 3 office blood pressure readings measured according to the BP guidelines. 2. 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. 3. Subject is \> 18 and \< 85 years of age. 4. Subject agrees to have all study procedures performed, and is competent and willing to provide written, informed consent to participate in this study. Key Exclusion Criteria: 1. 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. 2. Subject has aorto-ilio-femoral artery anatomy not suitable for treatment with the investigational device(s). 3. Subject has main renal arteries that are \< 20 mm in length or \< 4 mm in diameter. 4. Subject has a prior history of any renal artery intervention including but not limited to balloon angioplasty, stenting, renal denervation or surgery. 5. Subject has an estimated glomerular filtration rate (eGFR) of \< 45mL/min/1.73m2, using the MDRD formula. 6. Subject has type 1 diabetes mellitus. 7. 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. 8. 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.

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.

Time frame: 30 days post-procedure

Secondary Outcomes

Incidence of Adverse Cardiovascular and Renal Events Within the 12 Month Follow-up Visit

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.

Time frame: 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

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.

Time frame: 12 months post-procedure

Incidence of Subjects Achieving Target Systolic Blood Pressure (SBP) at 1, 3, 6 and 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.

Time frame: 12 months post-procedure

Data from ClinicalTrials.gov

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