Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography

Study Overview
=================
Brief 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.

Detailed Description
-----------------
This study will evaluate the effectiveness of CRT-D SonR system as compared to SoC programming methods to: Increase the rate of patients responding to CRT Provide appropriate hemodynamic cardiac effect, as expected from the Ritter method. The identification of CRT responders, as defined by echocardiography, generally refers to a significant reduction of the LV End-Systolic Diameter (LVESD) and/or LVESV during Follow-Up (FUp). Patients will be considered as responders to CRT if their LVESV decreased by > 15% after 6 months of CRT therapy as compared to baseline. The percentage of CRT responders will be compared between the two study arms. SoC is defined as the standard CRT system programming/optimization method currently used by physicians in study centers and any method may be used in the study if considered as routine practice in the study center.

Official Title
-----------------
Clinical Assessment of the SonR Algorithm in the PARADYM RF SonR CRT-D by Echocardiography

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: SonR CRT Optimization 'On'
* Device: SonR CRT Optimization 'Off'


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: CRT-D device
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SonR CRT Optimization 'On'<br>CRT-D device with the SonR optimization algorithm programmed being 'on'. | Device: SonR CRT Optimization 'On'<br>* Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.<br>|
| Other: SonR CRT Optimization 'Off'<br>CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care). | Device: SonR CRT Optimization 'Off'<br>* Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRT-responders rate increase based on LVESV decrease at M6 / baseline | For the purpose of this study, CRT-responders are defined as patients experiencing a decrease in LVESV of 15% or more at M6 Fup as most clinical trials used. The main objective of the SONR-ECHO trial is to show a minimum increase of CRT-responders rate of 15% (up to 72% or more) in the SonR study group as compared to SoC arm. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A-wave truncation assessment at M6 | The Ritter's method attempts to optimize AV and VV timings in dual-chamber PM patients. According to this method, AV delay is optimal when LVFT is maximal and mitral valve closure only occurs after atrial systole (A-wave) is complete. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CRT