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

Medtronic

Status: Terminated

Conditions: Heart Failure

Treatments: Procedure: Renal Denervation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01392196

TP085

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Single arm

Other group

Description:

Renal Denervation

Treatment:

Procedure: Renal Denervation