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MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
Sponsor: Central Hospital, Nancy, France
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
MRI screening
Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar
Implantable Loop Recorder
Inplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group
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