MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

NCT ID: NCT06269692

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1812 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2030-04-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MRI screening

Intervention Type: DEVICE

Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar

Implantable Loop Recorder

Intervention Type: DEVICE

Inplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group

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).

Group Type: OTHER

MRI screening

Intervention Type: DEVICE

Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar

Implantable Cardioverter Defibrillator

Intervention Type: DEVICE

Inplantation of the Implantable Cardioverter Defibrillator (ICD) for the patients assigned to the control group, according to the current guidelines

Interventions

MRI screening

Cardiac Magnetic Resonance imaging for the quantification of the infarct intramural scar

Intervention Type: DEVICE

Implantable Loop Recorder

Inplantation of the Implantable Loop Recorder (ILR) for the patients assigned to the experimental group

Intervention Type: DEVICE

Implantable Cardioverter Defibrillator

Inplantation of the Implantable Cardioverter Defibrillator (ICD) for the patients assigned to the control group, according to the current guidelines

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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;
• Use of maximum tolerated doses of ACE inhibitors (or Angiotensin II Receptor Blockers if intolerant of ACE) and Beta Blockers and MRA as per ESC guidelines;
• Person affiliated to or beneficiary of a social security plan
• Person informed about study organization and having signed the informed consent

Exclusion Criteria

• 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;
• Patient refusal of ICD/ILR implantation;
• Currently implanted permanent pacemaker and/or ICD;
• Clinical indication for or Cardiac Resynchronization Therapy (CRT);
• Severe renal insufficiency defined by a glomerular filtration rate (GFR) < 30 mL/min/1.73m²;
• Recent PTCA (within 30 days) or CABG (within 90 days);
• Baseline NYHA functional class IV;
• Contraindication for ICD implantation according to current guidelines;
• Woman of childbearing age without effective contraception;
• Person referred in articles L.1121-5, L. 1121-7 and L.1121-8 of the French Public Health Code.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Christian DE CHILLOU

Coordinating Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHRU Nancy

Vandœuvre-lès-Nancy, , France

Countries

France

Central Contacts

Christian de CHILLOU, MD, PhD

Role: CONTACT

c.dechillou@chru-nancy.fr

Guilaume DROUOT, PhD

Role: CONTACT

g.drouot@chru-nancy.fr

Facility Contacts

Christian de CHILLOU, MD, PhD

Role: primary

c.dechillou@chru-nancy.fr

Guillaume DROUOT, PhD

Role: backup

g.drouot@chru-nancy.fr

Other Identifiers

2023-A01353-42

Identifier Type: -

Identifier Source: org_study_id