Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction (WICD-MI)

March 9, 2023 updated by: Mathieu ECHIVARD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1032

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Auxerre, France, 89011
        • CH d'Auxerre
      • Besançon, France, 25030
        • CHU Besançon
      • Bezannes, France, 51430
        • Polyclinique Reims-Bezannes
      • Bordeaux, France
        • Chu Bordeaux Pessac
      • Boulogne-sur-Mer, France, 62200
        • CH Boulogne-sur-Mer
      • Brest, France, 29200
        • CHU Brest
      • Bron, France, 69500
        • Hospices Civils de Lyon
      • Caen, France
        • CHU de Caen
      • Clermont-Ferrand, France
        • Chu Clermont-Ferrand
      • Créteil, France, 94000
        • APHP Créteil
      • Dijon, France, 21000
        • CHU Dijon
      • Essey-lès-Nancy, France, 54270
        • Clinique Essey Les Nancy
      • La Tronche, France, 38700
        • CHU Grenoble
      • Lille, France
        • CHU Lille
      • Limoges, France, 87042
        • CHU Limoges
      • Lyon, France, 69004
        • Hospices Civils de Lyon
      • Marseille, France
        • Chu Aphm Marseille La Timone
      • Massy, France, 91300
        • Hôpital privé Jacques Cartier
      • Metz, France, 57530
        • Chr de Metz Thionville
      • Montpellier, France
        • Chu Montpellier
      • Nancy, France, 54100
        • Clinique Ambroise Pare
      • Nantes, France
        • CHU Nantes
      • Nîmes, France, 30900
        • Chu Nimes
      • Orléans, France, 54100
        • CHR d'Orléans
      • Paris, France, 75018
        • APHP Bichat
      • Paris, France
        • Php Hopital Europeen Georges Pompidou
      • Reims, France, 51092
        • CHU Reims
      • Rennes, France
        • CHU Rennes
      • Roubaix, France, 59100
        • CH de Roubaix
      • Rouen, France, 76038
        • CHU Rouen
      • Saint-Denis, France
        • Chu Aphp Salpetriere
      • Saint-Denis, France
        • Clinique Cardiologique Du Nord Saint-Denis
      • Saint-Étienne, France
        • CHU Saint-Etienne
      • Strasbourg, France, 67000
        • CHU Strasbourg
      • Toulouse, France
        • CHU Toulouse
      • Toulouse, France
        • Clinique Pasteur Toulouse
      • Tours, France
        • Chu Tours Saint-Avertin
      • Trévenans, France, 90400
        • Hôpital Nord Franche-Comté
      • Vandoeuvre-lès-Nancy, France
        • CHRU de Nancy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Study on Data
Study on Data

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.
Time Frame: Up to 7 years after ICD implantation
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).
Time Frame: 12 months and up to 7 years after ICD implantation]
12 months and up to 7 years after ICD implantation]
Rate of need to set-up left ventricular assist device (LVAD) or heart transplantation.
Time Frame: : 12 months and up to 7 years after ICD implantation
: 12 months and up to 7 years after ICD implantation
Rate of all-cause death.
Time Frame: 12 months and up to 7 years after ICD implantation
12 months and up to 7 years after ICD implantation
Rate of hospitalization for heart failure worsening.
Time Frame: 12 months and up to 7 years after ICD implantation
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.
Time Frame: Frame: 12 months and up to 7 years after ICD implantation
Frame: 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.
Time Frame: 12 months and up to 7 years after ICD implantation
12 months and up to 7 years after ICD implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mathieu ECHIVARD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2022

Primary Completion (Actual)

August 28, 2022

Study Completion (Actual)

September 8, 2022

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 9, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021PI163

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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