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NCT04347109 Clinical Trial

cArdiac Non Invasive MApping in resynchronizaTION

Cardiac Resynchronization Therapy Clinical Trial

— ANIMATION  

Official title:
cArdiac Non Invasive MApping in resynchronizaTION Registry

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT04347109
Other study ID # ANIMATION Registry
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date September 1, 2019
Est. completion date December 31, 2025

Study information
Verified date May 2024
Source University Hospital, Tours
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Suspended
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

  • Cardiac Resynchronization Therapy

Intervention

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

Locations
Country Name City State
France University Hospital of Tours Tours Please Select...

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

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