NCT01639378

Renal Artery Denervation in Chronic Heart Failure Study

Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The REACH study, is a prospective, double-blinded, randomised, controlled study of the safety and effectiveness of renal denervation in subjects with chronic systolic heart failure. Bilateral denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radio frequency (RF) energy through the luminal surface of the renal artery.

Detailed description

Interventional study Allocation: Randomised Endpoint Classification: Safety / Efficacy Study Intervention Model: Parallel Assignment Masking: Double blind (Subject / CHF team). The interventional operator, will have no role in care of the patient following randomisation. Primary Purpose: Treatment Chronic Systolic Heart Failure Device: Renal denervation (Symplicity Catheter System) Symplicity Catheter System -Intervention: Device: Renal denervation (Symplicity Catheter System) Patients are randomised in the cath lab to receive either renal denervation or sham procedure. Experimental arm: Renal Denervation Control arm: No renal denervation (sham procedure) In both arms, aftercare is provided by clinicians who are blinded to the randomised allocation arm. Subjects will have been recruited on stable heart failure therapy, and the intention is to maintain this therapy steady during followup.

Conditions

• Chronic Systolic Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Renal Denervation	Symplicity Catheter System

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-04-01
• First posted: 2012-07-12
• Last updated: 2016-11-11

Locations

1 site across 1 country: United Kingdom