MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France
About this trial
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.
Eligibility criteria
Qualifiers
Age > 18 years;
Patients with a LVEF≤35% assessed at least after a 40 to 90 days period (depending on the presence of coronary revascularization) following an index myocardial infarction;
Left ventricular systolic impairment as defined by LVEF≤35% by any current standard technique (echocardiogram, multiple gated acquisition scan, or MRI) within 2 months;
Able and willing to comply with all pre-, post- and follow-up testing, and requirements;
Disqualifiers
History of cardiac arrest or sustained VT or VF unless within 48 hours of an acute myocardial infarction;
Standard contraindications for cardiac LGE-MRI;
Hypersensitivity to gadolinium-based contrast agent;
Currently implanted permanent pacemaker and/or ICD;
Trial design
Treatments tested in this trial
- MRI screening
- Implantable Loop Recorder
- Implantable Cardioverter Defibrillator
Treatment groups
1,812 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov