Multi Point Pacing vs. Conventional STUDY PROTOCOL

Not Applicable

Withdrawn

• Conditions: Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy
• Interventions: Device: conventional CRT; Device: MPP CRT

• Registration Number: NCT04334018
• Lead Sponsor: CMC Ambroise Paré

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-31
• Study Start: 2018-03-01
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-02
• Last Update Submitted: 2020-04-02
• Study First Posted: 2020-04-03
• Last Update Posted: 2020-04-03
• Primary Completion: 2023-03-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
conventional CRT	conventional CRT	-
MPP CRT	MPP CRT	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

PHc hôpital d'Antibes la Fontonne; 🇫🇷 Antibes, France

Centre Hospitalier de Perpignan; 🇫🇷 Perpignan, France

CHU Nice; 🇫🇷 Nice, France

Centre Hospitalier Princesse Grace; 🇲🇨 Monaco, Monaco

Centre hospitalier de Cannes; 🇫🇷 Cannes, France

CMC Ambroise Paré; 🇫🇷 Neuilly sur seine, France