MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to implant a device called an implantable cardioverter-defibrillator (ICD) using advanced imaging techniques. The ICD is used to help prevent sudden cardiac death in patients who have had a heart attack and have a weakened heart function. Researchers want to see if guiding the ICD's placement with detailed imaging can improve the outcomes for patients, especially since many people with traditional ICDs do not benefit from them as expected.

To be eligible for this trial, participants need to be over 18 years old and have a specific level of heart function, measured as a low ejection fraction (LVEF ≤ 35%), at least 40 days after a heart attack. They should be on certain heart medications and agree to comply with study requirements. Participants will undergo the ICD implantation procedure and follow-up testing to monitor their health. It’s important to note that this study is not yet recruiting participants, so interested individuals will need to wait for further announcements.

Gender

ALL

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.