Overview

This trial is active, not recruiting.

Condition heart failure.
Treatments sonr crt optimization 'on', sonr crt optimization 'off'
Phase phase 4
Sponsor Sorin Group
Start date June 2013
End date May 2016
Trial size 328 participants
Trial identifier NCT01869062, ICSY01

Summary

The main objective of the SONR-ECHO trial is to demonstrate that optimization of CRT parameters by SonR technology is able to increase the rate of CRT-D responders, based on significant LV reverse remodeling, as compared to Standard of Care settings.

This study will also evaluate the effectiveness of CRT-D SonR system as compared to Standard of care (SoC) programming methods in providing appropriate LV filling, as expected from the Ritter method.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Arm
(Other)
CRT-D device with the SonR optimization algorithm programmed being 'on'.
sonr crt optimization 'on'
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.
(Other)
CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).
sonr crt optimization 'off'
Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).

Primary Outcomes

Measure
CRT-responders rate increase based on LVESV decrease at M6 / baseline
time frame: 6 months

Secondary Outcomes

Measure
A-wave truncation assessment at M6
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Eligible for implantation of a CRT-D device according to published relevant ESC and CCS guidelines ; - In Sinus Rhythm; - Have reviewed, signed and dated an informed consent Exclusion Criteria: - Previous implant with a pacemaker, an Implantable Cardioverter-Defibrillator or a CRT device (except upgrade from single chamber ICD with a fully functional defibrillation lead not under recall or surveillance); - Persistent atrial arrhythmias (or cardioversion for Atrial Fibrillation) within the past month; - Ventricular tachyarrhythmia secondary to reversible causes such as acute myocardial infarction (MI), digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment; - Incessant ventricular tachyarrhythmia; - Unstable angina, or acute MI, Coronary Artery Bypass-Grafting (CABG), or Percutaneous Transluminal Coronary Angioplasty (PTCA) within the past 4 weeks; - Correctable valvular disease that is the primary cause of heart failure; - Mechanical heart valve or indication for valve repair or replacement; - Recent Cerebro-Vascular Accident (CVA) or Transient Ischemic Attack (TIA) (within the previous 3 months); - Post heart transplant (patients who are waiting for a heart transplant are allowed in the study); - Already included in another clinical study that could confound the results of this study; - Life expectancy less than 1 year; - Inability to understand the purpose of the study; - Unavailability for scheduled follow-up or refusal to cooperate; - Sensitivity to 1 mg Dexamethasone Sodium Phosphate (DSP); - Age of less than 18 years; - Pregnancy; - Drug addiction or abuse; - Under guardianship

Additional Information

Official title Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography
Principal investigator François Philippon
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Sorin Group.