Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04334018
Recruitment Status : Withdrawn (Other studies on the same theme)
First Posted : April 3, 2020
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy Device: conventional CRT Device: MPP CRT Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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.
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. Outcome 1 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04334018


Locations
Layout table for location information
France
PHc hôpital d'Antibes la Fontonne
Antibes, France, 06606
Centre hospitalier de Cannes
Cannes, France, 06150
CMC Ambroise Paré
Neuilly sur seine, France, 92200
CHU Nice
Nice, France, 06100
Centre Hospitalier de Perpignan
Perpignan, France, 66000
Monaco
Centre Hospitalier Princesse Grace
Monaco, Monaco, 98000
Sponsors and Collaborators
CMC Ambroise Paré

Layout table for additonal information
Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT04334018    
Other Study ID Numbers: 2017/02
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases