NCT06269692

MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,812 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction
• Ventricular Tachycardia
• Ventricular Fibrillation
• Sudden Cardiac Death

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-01
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2024-02-21
• Last updated: 2024-02-21

Locations

1 site across 1 country: France