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MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

ConditionsMyocardial InfarctionVentricular TachycardiaVentricular FibrillationSudden Cardiac Death
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

1,812 Participants
are divided into 2 treatment groups
Group A: Implantable Loop RecorderExperimental treatment 2 interventions
Group B: Implantable Cardioverter DefibrillatorOther 2 interventions

Trial outcomes

Primary outcomes

1

Occurrence of Sudden Cardiac Death (SCD) during the follow-up period

Occurrence of SCD during the follow-up period, as defined by the World Health Organization in 10-ICD: death occurring within 24 hours from onset of symptoms.

Time frame
72 months

Secondary outcomes

1

Total number of deaths during the follow-up period

Time frame
72 months
2

Total number of deaths from cardiovascular cause during the follow-up period

Time frame
72 months
3

Total number of SCD due to ventricular arrhythmia during the follow-up period

Time frame
72 months
4

Total number (per patient) of sustained VT episodes treated by the ICD or recorded by the ILR during the follow-up period

Time frame
72 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Central Hospital, Nancy, France

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: