Last reviewed · How we verify
NCT06269692: SMART-DEF
MAgnetic Resonance Imaging-guided implanTation of Cardioverter DEFibrillators
NA trial testing MRI screening in Myocardial Infarction in 1,812 participants. Not yet recruiting.
1 April 2030
Quick facts
| Lead sponsor | Central Hospital, Nancy, France |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,812 |
| Start date | 1 April 2024 |
| Primary completion | 1 April 2030 |
| Estimated completion | 1 April 2030 |
| Sites | 1 location across France |
Drugs / interventions tested
- MRI screening
- Implantable Loop Recorder
- Implantable Cardioverter Defibrillator
Conditions studied
- Myocardial Infarction — all drugs for Myocardial Infarction →
- Ventricular Tachycardia — all drugs for Ventricular Tachycardia →
- Ventricular Fibrillation — all drugs for Ventricular Fibrillation →
- Sudden Cardiac Death — all drugs for Sudden Cardiac Death →
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.
Verify or expand the search:
- PubMed search for NCT06269692
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Central Hospital, Nancy, France trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06269692 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Central Hospital, Nancy, France
- Last refreshed: 21 February 2024
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.
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