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Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction

NCT ID: NCT05123885

Last Updated: 2023-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1032 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-02

Study Completion Date

2022-09-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Infarction, Myocardial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Experimental:

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.

Study on Data

Intervention Type OTHER

Study on Data

Interventions

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Study on Data

Study on Data

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mathieu ECHIVARD

OTHER

Sponsor Role lead

Responsible Party

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Mathieu ECHIVARD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Chu Amiens

Amiens, , France

Site Status

Ch D'Auxerre

Auxerre, , France

Site Status

Chu Besancon

Besançon, , France

Site Status

Polyclinique Reims-Bezannes

Bezannes, , France

Site Status

Chu Bordeaux Pessac

Bordeaux, , France

Site Status

Ch Boulogne-Sur-Mer

Boulogne-sur-Mer, , France

Site Status

Chu Brest

Brest, , France

Site Status

Hospices Civils de Lyon

Bron, , France

Site Status

CHU de Caen

Caen, , France

Site Status

Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Aphp Creteil

Créteil, , France

Site Status

Chu Dijon

Dijon, , France

Site Status

Clinique Essey Les Nancy

Essey-lès-Nancy, , France

Site Status

Chu Grenoble

La Tronche, , France

Site Status

Chu Lille

Lille, , France

Site Status

Chu Limoges

Limoges, , France

Site Status

Hospices Civils de Lyon

Lyon, , France

Site Status

Chu Aphm Marseille La Timone

Marseille, , France

Site Status

Hopital Prive Jacques Cartier

Massy, , France

Site Status

Chr de Metz Thionville

Metz, , France

Site Status

Chu Montpellier

Montpellier, , France

Site Status

Clinique Ambroise Pare

Nancy, , France

Site Status

Chu Nantes

Nantes, , France

Site Status

Chu Nimes

Nîmes, , France

Site Status

Chr D'Orleans

Orléans, , France

Site Status

Aphp Bichat

Paris, , France

Site Status

Php Hopital Europeen Georges Pompidou

Paris, , France

Site Status

Chu Reims

Reims, , France

Site Status

Chu Rennes

Rennes, , France

Site Status

Ch de Roubaix

Roubaix, , France

Site Status

Chu Rouen

Rouen, , France

Site Status

Chu Aphp Salpetriere

Saint-Denis, , France

Site Status

Clinique Cardiologique Du Nord Saint-Denis

Saint-Denis, , France

Site Status

Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Chu Strasbourg

Strasbourg, , France

Site Status

Chu Toulouse

Toulouse, , France

Site Status

Clinique Pasteur Toulouse

Toulouse, , France

Site Status

Chu Tours Saint-Avertin

Tours, , France

Site Status

Hopital Nord Franche-Comte

Trévenans, , France

Site Status

CHRU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2021PI163

Identifier Type: -

Identifier Source: org_study_id

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