protocolSection identificationModule nctId: NCT06269692, orgStudyIdInfo id: 2023-A01353-42, briefTitle: MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators, acronym: SMART-DEF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2030-04-01, completionDateStruct date: 2030-04-01, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Myocardial Infarction, conditions: Ventricular Tachycardia, conditions: Ventricular Fibrillation, conditions: Sudden Cardiac Death, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1812, type: ESTIMATED, armsInterventionsModule interventions name: MRI screening, interventions name: Implantable Loop Recorder, interventions name: Implantable Cardioverter Defibrillator, outcomesModule primaryOutcomes measure: Occurrence of Sudden Cardiac Death (SCD) during the follow-up period, secondaryOutcomes measure: Total number of deaths during the follow-up period, secondaryOutcomes measure: Total number of deaths from cardiovascular cause during the follow-up period, secondaryOutcomes measure: Total number of SCD due to ventricular arrhythmia during the follow-up period, secondaryOutcomes measure: Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period, secondaryOutcomes measure: Total number (per patient) of VF episodes treated by the ICD or recorded by the ILR during the follow-up period, secondaryOutcomes measure: Total number of hospitalizations due to cardiovascular causes during the follow-up period, secondaryOutcomes measure: Duration of hospitalizations due to cardiovascular causes during the follow-up period, secondaryOutcomes measure: Total number of hospitalizations from any cause during the follow-up period, secondaryOutcomes measure: Duration of hospitalizations from any cause during the follow-up period, secondaryOutcomes measure: Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period, secondaryOutcomes measure: Measurements of the estimated costs, secondaryOutcomes measure: Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences, secondaryOutcomes measure: Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences, secondaryOutcomes measure: Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar, secondaryOutcomes measure: Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHRU Nancy, city: Vandœuvre-lès-Nancy, zip: 54511, country: France, contacts name: Christian de CHILLOU, MD, PhD, role: CONTACT, email: c.dechillou@chru-nancy.fr, contacts name: Guillaume DROUOT, PhD, role: CONTACT, email: g.drouot@chru-nancy.fr, geoPoint lat: 48.65, lon: 6.18333, hasResults: False