MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

NCT06269692 | Not Yet Recruiting DMC

• 1 other identifier: 2023-A01353-42
• Study Type: interventional
• Target: 1,812
• Locations: 1 country
• Sites: 1

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

Keywords

Myocardial Infarction

Outcome Measures

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.

  72 months

Secondary Outcomes (15)

• Total number of deaths during the follow-up period

  72 months

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

  72 months

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

  72 months

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

  72 months

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

  72 months

Study Arms (2)

Implantable Loop Recorder

EXPERIMENTAL

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.

Device: MRI screening; Device: Implantable Loop Recorder

Implantable Cardioverter Defibrillator

OTHER

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).

Device: MRI screening; Device: Implantable Cardioverter Defibrillator

Interventions

MRI screening DEVICE

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

Implantable Cardioverter Defibrillator; Implantable Loop Recorder

Implantable Loop Recorder DEVICE

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

Implantable Loop Recorder

Implantable Cardioverter Defibrillator DEVICE

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

Implantable Cardioverter Defibrillator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Myocardial Infarction; Tachycardia, Ventricular; Ventricular Fibrillation; Death, Sudden, Cardiac

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Tachycardia; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Heart Arrest; Death, Sudden; Death

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Central Study Contacts

Christian de CHILLOU, MD, PhD

CONTACT

c.dechillou@chru-nancy.fr

Guilaume DROUOT, PhD

CONTACT

g.drouot@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 21, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)