Multi Point Pacing vs. Conventional STUDY PROTOCOL

Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy Clinical Trial

— CRT-MPP  

Official title:

Observational, Multicentre, Investigator and Patient Blinded, Prospective, Randomized Comparator Study of Cardiac Resynchronization Therapy (CRT) Multi Point Pacing (MPP) Compared to Conventional CRT Pacing Response in Heart Failure Patients.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04334018
• Other study ID #: 2017/02
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2023

Study information

• Verified date: April 2020
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

• Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy
• Heart Failure

Intervention

Device:
• conventional CRT
Conventional CRT or biventricular pacing "resynchronizes" left ventricular contraction by pacing the right and left ventricles (LV) simultaneously
• MPP CRT
CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously

Locations

Country	Name	City	State
France	PHc hôpital d'Antibes la Fontonne	Antibes
France	Centre hospitalier de Cannes	Cannes
France	CMC Ambroise Paré	Neuilly sur seine
France	CHU Nice	Nice
France	Centre Hospitalier de Perpignan	Perpignan
Monaco	Centre Hospitalier Princesse Grace	Monaco

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome 1	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.	12 months