Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy
Conditions
Brief summary
The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy
Interventions
Conventional CRT or biventricular pacing resynchronizes left ventricular contraction by pacing the right and left ventricles (LV) simultaneously
CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months
Exclusion criteria
* \< 18 years and younger * Pregnant or breastfeeding patients * Non-LBBB patients (RBBB, intra-ventricular delay) * Non-ambulatory NYHA class IV effort tolerance * Myocardial infarction within 40 days before enrolment * Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months * Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery) * Patients with life expectancy of less than 12 months due to other medical conditions * Patients who are involved in another investigational study (device or medical)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome 1 | 12 months | To evaluate the clinical improvement of CRT MPP as compared to conventional CRT in Heart Failure patients with indication for CRT using automated intra-cardiac EGMs analysis (QuickOpt™) for device optimization, in a large multicentre international study. |
Countries
France, Monaco