Chronic Systolic Heart Failure Clinical Trial
Official title:
Impact of Renal Artery Denervation in Patients With Chronic Heart Failure Compared With Sham Procedure
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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