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NCT06269692: SMART-DEF

MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators

Not yet recruiting NA Last updated 21 February 2024
What this trial tests

NA trial testing MRI screening in Myocardial Infarction in 1,812 participants. Not yet recruiting.

Timeline
1 April 2024
Primary endpoint
1 April 2030
1 April 2030

Quick facts

Lead sponsorCentral Hospital, Nancy, France
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment1,812
Start date1 April 2024
Primary completion1 April 2030
Estimated completion1 April 2030
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Central Hospital, Nancy, France

Who can join

18 and older, any sex, with Myocardial Infarction or Ventricular Tachycardia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of MRI screening

Trials testing the same drug.

Other recruiting trials for Myocardial Infarction

Currently open trials in the same condition.

Other Central Hospital, Nancy, France trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06269692.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing