NCT05123885

Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction

Impact Pronostique d'un événement Rythmique Ventriculaire Durant le Port de la LifeVest en Post-infarctus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,032 (actual)
• Sponsor: Mathieu ECHIVARD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Sudden death from ventricular arrhythmia is a serious and common complication of myocardial infarction, especially with low left ventricular ejection fraction (LVEF). Implantable cardiac defibrillator (ICD) implantation is currently recommended at three months of optimal medical treatment in patients who have had a myocardial infarction and have a LVEF below 35%. This strategy indeed allows a reduction in mortality while early post-infarction implantation showed no benefit in terms of survival. However, the risk of sudden death at this period is the greatest and the temporary defibrillator vest, marketed under the name LifeVest, is now indicated in the early post-infarction period in patients with LVEF less than 35%. Indeed, the LifeVest would allow a reduction in sudden death of rhythmic origin in the first three months post-infarction. No study has yet investigated the prognostic significance of a ventricular rhythm disorder (ventricular tachycardia \[VT\] or ventricular fibrillation \[VF\]) occurring during this early and short (approximately 3 months) particular period of wearing the LifeVest: is this a random event, or is it an event predictive of a rhythmic recurrence? The aim of the study is to assess the association between the occurrence of a sustained ventricular rhythm disorder in the early post-infarction period, during the period of wearing the LifeVest (ventricular episodes detected, treated or not), and the risk of rhythmic recurrence at 12 months.

Conditions

• Infarction, Myocardial

Interventions

Type	Name	Description
OTHER	Study on Data	Study on Data

Timeline

• Start date: 2022-02-02
• Primary completion: 2022-08-28
• Completion: 2022-09-08
• First posted: 2021-11-17
• Last updated: 2023-03-10

Locations

40 sites across 1 country: France