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Multi Point Pacing vs. Conventional STUDY PROTOCOL (CRT-MPP)

Primary Purpose

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

Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
conventional CRT
MPP CRT
Sponsored by
CMC Ambroise Paré
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • PHc hôpital d'Antibes la Fontonne
  • Centre hospitalier de Cannes
  • CMC Ambroise Paré
  • CHU Nice
  • Centre Hospitalier de Perpignan
  • Centre Hospitalier Princesse Grace

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

conventional CRT

MPP CRT

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2018
Last Updated
April 2, 2020
Sponsor
CMC Ambroise Paré
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1. Study Identification

Unique Protocol Identification Number
NCT04334018
Brief Title
Multi Point Pacing vs. Conventional STUDY PROTOCOL
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Other studies on the same theme
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CMC Ambroise Paré

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional CRT
Arm Type
Placebo Comparator
Arm Title
MPP CRT
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
conventional CRT
Intervention Description
Conventional CRT or biventricular pacing "resynchronizes" left ventricular contraction by pacing the right and left ventricles (LV) simultaneously
Intervention Type
Device
Intervention Name(s)
MPP CRT
Intervention Description
CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously
Primary Outcome Measure Information:
Title
Outcome 1
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
PHc hôpital d'Antibes la Fontonne
City
Antibes
ZIP/Postal Code
06606
Country
France
Facility Name
Centre hospitalier de Cannes
City
Cannes
ZIP/Postal Code
06150
Country
France
Facility Name
CMC Ambroise Paré
City
Neuilly sur seine
ZIP/Postal Code
92200
Country
France
Facility Name
CHU Nice
City
Nice
ZIP/Postal Code
06100
Country
France
Facility Name
Centre Hospitalier de Perpignan
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Centre Hospitalier Princesse Grace
City
Monaco
ZIP/Postal Code
98000
Country
Monaco

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Multi Point Pacing vs. Conventional STUDY PROTOCOL

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