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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Renal Denervation

Group Type OTHER

Renal Denervation

Intervention Type PROCEDURE

Renal Denervation using the Symplicity Catheter in Heart Failure Population

Interventions

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Renal Denervation

Renal Denervation using the Symplicity Catheter in Heart Failure Population

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No