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NOT YET RECRUITING
NCT06269692
NA

MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

Sponsor: Central Hospital, Nancy, France

View on ClinicalTrials.gov

Summary

Implantable cardioverter-defibrillators (ICD) are currently recommended for the primary prevention of sudden cardiac death (SCD) in patients with a remote (\>6 weeks) myocardial infarction (MI) and a low (≤35%) left ventricular ejection fraction (LVEF). Ventricular tachycardia (VT) and/or ventricular fibrillation (VF), which are responsible for most SCDs, result from the presence of surviving myocytes embedded within fibrotic MI-scar. The presence of these surviving myocytes, as well as their specific arrhythmic characteristics, is not captured by LVEF. Hence, the use of LVEF as a unique risk-stratifier of SCD results in a low proportion (17 to 31%) of appropriate ICD device therapy at 2 years. Consequently, most patients with a prophylactic ICD do not present VT/VF requiring ICD therapy prior to their first-ICD battery depletion. Thus, many patients are exposed to ICD complications, such as inappropriate shocks, without deriving any health benefit. Therefore, the current implantation strategy of prophylactic ICDs, based on LVEF only, needs to be improved in post-MI patients.

Official title: Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1812

Start Date

2024-04-01

Completion Date

2030-04-01

Last Updated

2024-02-21

Healthy Volunteers

No

Interventions

DEVICE

MRI screening

Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar

DEVICE

Implantable Loop Recorder

Inplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group

DEVICE

Implantable Cardioverter Defibrillator

Inplantation of the Implantable Cardioverter Defibrillator (ICD) for the patients assigned to the control group, according to the current guidelines

Locations (1)

CHRU Nancy

Vandœuvre-lès-Nancy, France