Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction

Completed

• Conditions: Infarction, Myocardial

• Registration Number: NCT05123885
• Lead Sponsor: Mathieu ECHIVARD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-17
• Study Start: 2022-02-02
• Primary Completion: 2022-08-28
• Study Completion: 2022-09-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1032

Inclusion Criteria

• Adult patients who benefited, between the start of 2015 and January 1, 2021, from a LifeVest after a myocardial infarction, followed by the implantation of an ICD before March 1, 2021.

Exclusion Criteria

• Patient opposition to the use of their data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.	12 months after ICD implantation

Secondary Outcome Measures

Name	Time	Method
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.	Up to 7 years after ICD implantation
Rate of need to set-up left ventricular assist device (LVAD) or heart transplantation.	: 12 months and up to 7 years after ICD implantation
Rate of all-cause death.	12 months and up to 7 years after ICD implantation
Rate of rhythmic storm defined by ACC / AHA / ESC 2006 guidelines (≥3 episodes of VF, sustained VT or appropriate shock in 24 hours).	12 months and up to 7 years after ICD implantation]
Rate of hospitalization for heart failure worsening.	12 months and up to 7 years after ICD implantation
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD, and mortality from any cause.	12 months and up to 7 years after ICD implantation

Trial Locations

Locations (39)

Chu Amiens; 🇫🇷 Amiens, France

Ch D'Auxerre; 🇫🇷 Auxerre, France

Chu Besancon; 🇫🇷 Besançon, France

Polyclinique Reims-Bezannes; 🇫🇷 Bezannes, France

Chu Bordeaux Pessac; 🇫🇷 Bordeaux, France

Ch Boulogne-Sur-Mer; 🇫🇷 Boulogne-sur-Mer, France

Chu Brest; 🇫🇷 Brest, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

CHU de Caen; 🇫🇷 Caen, France

Chu Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

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