cArdiac Non Invasive MApping in resynchronizaTION (ANIMATION)

May 11, 2024 updated by: Laurent Fauchier, University Hospital, Tours

cArdiac Non Invasive MApping in resynchronizaTION Registry

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Please Select...
      • Tours, Please Select..., France, 37000
        • University hospital of Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients referred for change or upgrading of a right ventricular pacing device in our center (CHU Tours).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventricular activation map
Time Frame: Up to 6 months
Differences (qualitative and quantitative measurements) in ventricular activation patterns are identified.
Up to 6 months
Response to CRT
Time Frame: Up to 2 years
Composite endpoint : volumetric response, heart failure hospitalizations, and all-cause mortality.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 8, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ANIMATION Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Access Criteria

Upon submission to a peer-reviewed journal.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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