Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial
Not Applicable
Terminated
- Conditions
- Heart Failure
- Interventions
- Procedure: Renal Denervation
- Registration Number
- NCT01392196
- Lead Sponsor
- Medtronic Vascular
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 39
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm Renal Denervation Renal Denervation
- Primary Outcome Measures
Name Time Method Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events 6 month
- Secondary Outcome Measures
Name Time Method Ventricular function as measured by Echocardiography 6 month Renal function as measured by Glomerular Filtration Rate (GFR) 6 months
Trial Locations
- Locations (1)
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia