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CRT-MPP: Multi Point Pacing vs. Conventional STUDY PROTOCOL

Sponsor
CMC Ambroise Paré (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04334018
Collaborator
(none)
0
Enrollment
6
Locations
2
Arms
60
Anticipated Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Device: conventional CRT
  • Device: MPP CRT
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
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.
Anticipated Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: conventional CRT

Device: conventional CRT
Conventional CRT or biventricular pacing "resynchronizes" left ventricular contraction by pacing the right and left ventricles (LV) simultaneously
Experimental: MPP CRT

Device: MPP CRT
CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 PHc hôpital d'Antibes la Fontonne Antibes France 06606
2 Centre hospitalier de Cannes Cannes France 06150
3 CMC Ambroise Paré Neuilly sur seine France 92200
4 CHU Nice Nice France 06100
5 Centre Hospitalier de Perpignan Perpignan France 66000
6 Centre Hospitalier Princesse Grace Monaco Monaco 98000

Sponsors and Collaborators

  • CMC Ambroise Paré

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CMC Ambroise Paré
ClinicalTrials.gov Identifier:
NCT04334018
Other Study ID Numbers:
  • 2017/02
First Posted:
Apr 3, 2020
Last Update Posted:
Apr 3, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Apr 3, 2020