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NCT Number: NCT06269692

MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: 72 months

    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.

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

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

    Time frame: 72 months

  6. Total number of hospitalizations due to cardiovascular causes during the follow-up period

    Time frame: 72 months

  7. Duration of hospitalizations due to cardiovascular causes during the follow-up period

    Time frame: 72 months

  8. Total number of hospitalizations from any cause during the follow-up period

    Time frame: 72 months

  9. Duration of hospitalizations from any cause during the follow-up period

    Time frame: 72 months

  10. Quality of life assessed by the scoring obtained from EuroQol questionnaires (EQ-5D-5L) during the follow-up period

    Time frame: 72 months

  11. Measurements of the estimated costs

    Time frame: 72 months

    Measurements of the estimated costs for the National Health Insurance System (NHIS) in the different arms of the trial

  12. Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences

    Time frame: 36 months

    Dice scores of the segmentation of the left ventricle and scar obtained from new MR sequences, LGE segmentation by cardiologists/radiologists as the ground truth

  13. Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences

    Time frame: 36 months

    Contour distance metrics of the segmentation of the left ventricle and scar obtained from new MR sequences, LGE segmentation by cardiologists/radiologists as the ground truth

  14. Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar

    Time frame: 36 months

    Dice scores of the accuracy of fully automated segmentation of the left ventricle and scar, using manually corrected segmentation by cardiologists/radiologists as the ground truth

  15. Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar

    Time frame: 36 months

    Contour distance metrics of the accuracy of fully automated segmentation of the left ventricle and scar, using manually corrected segmentation by cardiologists/radiologists as the ground truth

Study contacts

Contact information is provided by the study sponsor or research team.

Christian de CHILLOU, MD, PhD

CONTACT

[email protected]

Guilaume DROUOT, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

Multicenter randomiSed Trial on MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

Acronym: SMART-DEF

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Feb 21, 2024
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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