MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

Sponsor
Central Hospital, Nancy, France
Study ID
NCT06269692
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MRI screening — DEVICE
    Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar
  • Implantable Loop Recorder — DEVICE
    Inplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group
  • Implantable Cardioverter Defibrillator — DEVICE
    Inplantation of the Implantable Cardioverter Defibrillator (ICD) for the patients assigned to the control group, according to the current guidelines

Study Details

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.

Key Dates

First listed
Feb 21, 2024
Start date
Apr 1, 2024
Status verified
Feb 2024
Primary completion
Apr 1, 2030
Completion
Apr 1, 2030

Study Design

Enrollment
1,812 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Implantable Loop Recorder
    Patients identified at very low-risk of VT/VF randomized to be implanted with an ILR (experimental strategy). Following randomization, these patients will be followed using remote ILR monitoring.
  • Other: Implantable Cardioverter Defibrillator
    Patients identified at very low-risk of VT/VF randomized to be implanted with an ICD (reference strategy), which corresponds to the currently recommended treatment in post-MI patients with a LVEF ≤35% (European Society of Cardiology guidelines 2015) (Zeppenfeld et al., 2022).

Primary Outcome Measure

Occurrence of Sudden Cardiac Death (SCD) during the follow-up period [ Time Frame: 72 months ]

Central Contacts

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