Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction
WICD-MI
Impact Pronostique d'un événement Rythmique Ventriculaire Durant le Port de la LifeVest en Post-infarctus
1 other identifier
observational
1,032
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2022
Shorter than P25 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2021
CompletedFirst Posted
Study publicly available on registry
November 17, 2021
CompletedStudy Start
First participant enrolled
February 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2022
CompletedMarch 10, 2023
March 1, 2023
7 months
November 9, 2021
March 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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 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 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 hospitalization for heart failure worsening.
12 months and up to 7 years after ICD implantation
- +2 more secondary outcomes
Study Arms (1)
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.
Interventions
Eligibility Criteria
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
You may qualify if:
- 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.
You may not qualify if:
- Patient opposition to the use of their data.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mathieu ECHIVARDlead
Study Sites (40)
Chu Amiens
Amiens, 80054, France
Ch D'Auxerre
Auxerre, 89011, France
Chu Besancon
Besançon, 25030, France
Polyclinique Reims-Bezannes
Bezannes, 51430, France
Chu Bordeaux Pessac
Bordeaux, France
Ch Boulogne-Sur-Mer
Boulogne-sur-Mer, 62200, France
Chu Brest
Brest, 29200, France
Hospices Civils de Lyon
Bron, 69500, France
CHU de Caen
Caen, France
Chu Clermont-Ferrand
Clermont-Ferrand, France
Aphp Creteil
Créteil, 94000, France
Chu Dijon
Dijon, 21000, France
Clinique Essey Les Nancy
Essey-lès-Nancy, 54270, France
Chu Grenoble
La Tronche, 38700, France
Chu Lille
Lille, France
Chu Limoges
Limoges, 87042, France
Hospices Civils de Lyon
Lyon, 69004, France
Chu Aphm Marseille La Timone
Marseille, France
Hopital Prive Jacques Cartier
Massy, 91300, France
Chr de Metz Thionville
Metz, 57530, France
Chu Montpellier
Montpellier, France
Clinique Ambroise Pare
Nancy, 54100, France
Chu Nantes
Nantes, France
Chu Nimes
Nîmes, 30900, France
Chr D'Orleans
Orléans, 54100, France
Aphp Bichat
Paris, 75018, France
Php Hopital Europeen Georges Pompidou
Paris, France
Chu Reims
Reims, 51092, France
Chu Rennes
Rennes, France
Ch de Roubaix
Roubaix, 59100, France
Chu Rouen
Rouen, 76038, France
Chu Aphp Salpetriere
Saint-Denis, France
Clinique Cardiologique Du Nord Saint-Denis
Saint-Denis, France
Chu Saint-Etienne
Saint-Etienne, France
Chu Strasbourg
Strasbourg, 67000, France
Chu Toulouse
Toulouse, France
Clinique Pasteur Toulouse
Toulouse, France
Chu Tours Saint-Avertin
Tours, France
Hopital Nord Franche-Comte
Trévenans, 90400, France
CHRU de Nancy
Vandœuvre-lès-Nancy, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 9, 2021
First Posted
November 17, 2021
Study Start
February 2, 2022
Primary Completion
August 28, 2022
Study Completion
September 8, 2022
Last Updated
March 10, 2023
Record last verified: 2023-03