RESPOND-CRT Trial

A prospective, multicentre, randomized, double-blind study designed to evaluate the safety and efficacy of the SonR system.

Design

RESPOND-CRT is an International, multicenter, randomized (2:1), prospective, non-inferiority study.1

Patients

  • LVEF ≤ 35%
  • QRS ≥ 120 ms in LBBB or QRS ≥ 150 ms in non-LBBB
  • NYHA III or IV
  • Without permanent AF

Enrollment

  • 125 sites in Europe, USA, Australia
  • Jan 2012 – Oct 2014
  • Long term follow up ongoing (2 years)

Primary Efficacy Endpoint

Non-inferiority on the proportion of responders, based on a clinical composite of criteria (10% non-inferiority margin), at 12 months

Primary Safety Endpoint

Freedom from acute (0-3 months) and chronic (3-12 months) SonRtip lead complications

Secondary Endpoints

  • All-cause death or HF hospitalization
  • Worsened patients
  • Subgroups analysis on the primary efficacy endpoint

References:

  • 1. Brugada J, Brachmann J, Delnoy PP et al. Automatic optimization of cardiac resynchronization therapy using SonR-rationale and design of the Clinical trial of the SonRtip lead and Automatic AV-VV optimization Algorithm in the Paradym RF SonR CRT-D (RESPOND CRT) trial. Am Heart J , 2014 ; Vol 167 (4):429-435

Hear from the experts

Where do we stand after two decades of trying to find the right CRT optimization strategy? Experts discuss the results of the RESPOND-CRT trial and the implications for clinical practice.

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The Respond-CRT System

SonR technology is available exclusively in LivaNova devices. Learn more about the Platinium SonR family of CRT-D devices.

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