Heart Failure
Conditions
Keywords
Renal Impairment
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.
Interventions
PROCEDURERenal Denervation
Renal Denervation using the Symplicity Catheter in Heart Failure Population
Sponsors
Medtronic Vascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of Renal Denervation in Heart Failure patients as measured by Adverse Events | 6 month |
Secondary
| Measure | Time frame |
|---|---|
| Ventricular function as measured by Echocardiography | 6 month |
| Renal function as measured by Glomerular Filtration Rate (GFR) | 6 months |
Countries
Australia
Outcome results
None listed