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

Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment

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.

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