Clinical trial NCT05123885: Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction
Official title: Impact Pronostique d'un événement Rythmique Ventriculaire Durant le Port de la LifeVest en Post-infarctus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infarction, Myocardial
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 1032
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.
timeFrame: 12 months after ICD implantation
Secondary outcomes:
measure: Rate of rhythmic recurrence defined as the occurrence of a sustained or treated ventricular rhythm disorder (VT or VF) during monitoring of the ICD.
timeFrame: Up to 7 years after ICD implantation
measure: Rate of rhythmic storm defined by ACC / AHA / ESC 2006 guidelines (≥3 episodes of VF, sustained VT or appropriate shock in 24 hours).
timeFrame: 12 months and up to 7 years after ICD implantation]
measure: Rate of need to set-up left ventricular assist device (LVAD) or heart transplantation.
timeFrame: : 12 months and up to 7 years after ICD implantation
measure: Rate of all-cause death.
timeFrame: 12 months and up to 7 years after ICD implantation
measure: Rate of hospitalization for heart failure worsening.
timeFrame: 12 months and up to 7 years after ICD implantation
measure: 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.
timeFrame: Frame: 12 months and up to 7 years after ICD implantation
measure: 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.
timeFrame: 12 months and up to 7 years after ICD implantation
Other outcomes:
Locations:
city: Amiens
country: France
facility: Chu Amiens
city: Auxerre
country: France
facility: Ch D'Auxerre
city: Besançon
country: France
facility: Chu Besancon
city: Bezannes
country: France
facility: Polyclinique Reims-Bezannes
city: Bordeaux
country: France
facility: Chu Bordeaux Pessac
city: Boulogne-sur-Mer
country: France
facility: Ch Boulogne-Sur-Mer
city: Brest
country: France
facility: Chu Brest
city: Bron
country: France
facility: Hospices Civils de Lyon
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: Chu Clermont-Ferrand
city: Créteil
country: France
facility: Aphp Creteil
city: Dijon
country: France
facility: Chu Dijon
city: Essey-lès-Nancy
country: France
facility: Clinique Essey Les Nancy
city: La Tronche
country: France
facility: Chu Grenoble
city: Lille
country: France
facility: Chu Lille
city: Limoges
country: France
facility: Chu Limoges
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Marseille
country: France
facility: Chu Aphm Marseille La Timone
city: Massy
country: France
facility: Hopital Prive Jacques Cartier
city: Metz
country: France
facility: Chr de Metz Thionville
city: Montpellier
country: France
facility: Chu Montpellier
city: Nancy
country: France
facility: Clinique Ambroise Pare
city: Nantes
country: France
facility: Chu Nantes
city: Nîmes
country: France
facility: Chu Nimes
city: Orléans
country: France
facility: Chr D'Orleans
city: Paris
country: France
facility: Aphp Bichat
city: Paris
country: France
facility: Php Hopital Europeen Georges Pompidou
city: Reims
country: France
facility: Chu Reims
city: Rennes
country: France
facility: Chu Rennes
city: Roubaix
country: France
facility: Ch de Roubaix
city: Rouen
country: France
facility: Chu Rouen
city: Saint-Denis
country: France
facility: Chu Aphp Salpetriere
city: Saint-Denis
country: France
facility: Clinique Cardiologique Du Nord Saint-Denis
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
city: Strasbourg
country: France
facility: Chu Strasbourg
city: Toulouse
country: France
facility: Chu Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
city: Tours
country: France
facility: Chu Tours Saint-Avertin
city: Trévenans
country: France
facility: Hopital Nord Franche-Comte
city: Vandoeuvre-lès-Nancy
country: France
facility: CHRU de Nancy
Study officials:
References: