Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial

Medtronic Vascular39 enrolled

Overview

This is a feasibility study enrolling up to 40 patients in Australia and Europe. The primary aim of the study is to demonstrate the renal denervation with the Symplicity Catheter is safe and determine the evidence of a response to renal denervation in patients with Heart Failure.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Renal DenervationPROCEDURE

Renal Denervation using the Symplicity Catheter in Heart Failure Population

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Heart Failure patients NYHA Class II or III * Renal Impairment Left Ventricular Ejection Function \<40% * GFR 30 to 75 mL/min/1.73m2 * Optimal stable medical therapy Exclusion Criteria: * Renal artery anatomy must be eligible for treatment as determined by Angiography, and * History of prior renal artery intervention * Single functioning kidney. * Myocardial Infarction, unstable angina pectoris or cerebrovascular Accident within 3 months * Systolic BP \< 90 mmHG

Locations (1)

Alfred Hospital

Melbourne, Victoria, Australia

Outcomes

Primary Outcomes

Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events

Time frame: 6 month

Secondary Outcomes

Ventricular function as measured by Echocardiography

Time frame: 6 month

Renal function as measured by Glomerular Filtration Rate (GFR)

Time frame: 6 months

Data from ClinicalTrials.gov

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