cArdiac Non Invasive MApping in resynchronizaTION

Suspended

• Conditions: Cardiac Resynchronization Therapy
• Interventions: Diagnostic Test: Non invasive epicardial mapping

• Registration Number: NCT04347109
• Lead Sponsor: University Hospital, Tours

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.

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 Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-04-08
• Study First Submitted QC: 2020-04-10
• Study First Posted: 2020-04-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-11
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biventricular Pacing	Non invasive epicardial mapping	Patients implanted with a device enabling cardiac resynchronization therapy.
Right Ventricular Pacing	Non invasive epicardial mapping	Patients implanted with a right ventricular pacing device.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital of Tours; 🇫🇷 Tours, Please Select..., France