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ANIMATION: cArdiac Non Invasive MApping in resynchronizaTION

Sponsor
University Hospital, Tours (Other)
Overall Status
Recruiting
CT.gov ID
NCT04347109
Collaborator
(none)
50
Enrollment
1
Location
40
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Non-invasive mapping using the Cardio Insight system is performed in heart failure patients requiring biventricular pacing to optimize therapy, and understand mechanisms underlying pacing-induced cardiomyopathy and ventricular arrhythmias.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Non invasive epicardial mapping

Detailed Description

Non-invasive mapping using the Cardio Insight system is prospectively performed routinely in heart failure patients requiring cardiac resynchronization therapy.

Control patients are included, requiring chronic permanent right ventricular pacing.

Specific focus include: optimization of programming parameters, pacing-induced cardiomyopathy, ventricular arrhythmias, defibrillation threshold testing and electrical shocks.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
cArdiac Non Invasive MApping in resynchronizaTION Registry
Actual Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Biventricular Pacing

Patients implanted with a device enabling cardiac resynchronization therapy.

Diagnostic Test: Non invasive epicardial mapping
Non invasive mapping using Cardio Insight system is performed in all included patients.
Other Names:
  • Cardio Insight system
  • ECG imaging

    		•
    Right Ventricular Pacing

    Patients implanted with a right ventricular pacing device.

    Diagnostic Test: Non invasive epicardial mapping
    Non invasive mapping using Cardio Insight system is performed in all included patients.
    Other Names:
  • Cardio Insight system
  • ECG imaging

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ventricular activation map [Up to 6 months]

      Differences (qualitative and quantitative measurements) in ventricular activation patterns are identified.

    2. Response to CRT [Up to 2 years]

      Composite endpoint : volumetric response, heart failure hospitalizations, and all-cause mortality.

    Eligibility Criteria

    Criteria

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

    • Patients implanted with a biventricular pacing device (CRT) device

    • Patients chronically implanted with a right ventricular pacing device.

    Exclusion Criteria:
    • Age <18 years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital of Tours Tours Please Select... France 37000

    Sponsors and Collaborators

    • University Hospital, Tours

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laurent Fauchier, Professor, University Hospital, Tours
    ClinicalTrials.gov Identifier:
    NCT04347109
    Other Study ID Numbers:
    • ANIMATION Registry
    First Posted:
    Apr 15, 2020
    Last Update Posted:
    Apr 15, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Laurent Fauchier, Professor, University Hospital, Tours
    non invasive mapping
    cardiac resynchronization therapy
    pacing-induced cardiomyopathy
    electrical shock

    Study Results

    No Results Posted as of Apr 15, 2020