Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography
This trial is active, not recruiting.
|Treatments||sonr crt optimization 'on', sonr crt optimization 'off'|
|Start date||June 2013|
|End date||May 2016|
|Trial size||328 participants|
|Trial identifier||NCT01869062, ICSY01|
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.
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
CRT-responders rate increase based on LVESV decrease at M6 / baseline
time frame: 6 months
A-wave truncation assessment at M6
time frame: 6 months
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
|Official title||Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography|
|Principal investigator||François Philippon|
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