cArdiac Non Invasive MApping in resynchronizaTION

NCT04347109 | Suspended

• 1 other identifier: ANIMATION Registry
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Resynchronization Therapy

Keywords

non invasive mapping; cardiac resynchronization therapy; pacing-induced cardiomyopathy; electrical shock

Outcome Measures

Primary Outcomes (2)

• Ventricular activation map

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

  Up to 6 months

• Response to CRT

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

  Up to 2 years

Study Arms (2)

Biventricular Pacing

Patients implanted with a device enabling cardiac resynchronization therapy.

Diagnostic Test: Non invasive epicardial mapping

Right Ventricular Pacing

Patients implanted with a right ventricular pacing device.

Diagnostic Test: Non invasive epicardial mapping

Interventions

Non invasive epicardial mapping DIAGNOSTIC_TEST

Non invasive mapping using Cardio Insight system is performed in all included patients.

Also known as: Cardio Insight system, ECG imaging

Biventricular Pacing; Right Ventricular Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients implanted with a biventricular pacing device (CRT) device
• Patients chronically implanted with a right ventricular pacing device.

You may not qualify if:

• Age \<18 years

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

University Hospital of Tours

Tours, Please Select..., 37000, France

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2020
• Study Start: September 1, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Upon submission to a peer-reviewed journal.

Locations

FR (1)