Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction

Infarction, Myocardial Clinical Trial

— WICD-MI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05123885
• Other study ID #: 2021PI163
• Status: Completed
• Start date: February 2, 2022
• Est. completion date: September 8, 2022

Study information

• Verified date: March 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1032
• Est. completion date: September 8, 2022
• Est. primary completion date: August 28, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Infarction, Myocardial
• Myocardial Infarction

Intervention

Other:
• Study on Data
Study on Data

Locations

Country	Name	City	State
France	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	Bron
France	CHU de Caen	Caen
France	Chu Clermont-Ferrand	Clermont-Ferrand
France	Aphp Creteil	Créteil
France	Chu Dijon	Dijon
France	Clinique Essey Les Nancy	Essey-lès-Nancy
France	Chu Grenoble	La Tronche
France	Chu Lille	Lille
France	Chu Limoges	Limoges
France	Hospices Civils de Lyon	Lyon
France	Chu Aphm Marseille La Timone	Marseille
France	Hopital Prive Jacques Cartier	Massy
France	Chr de Metz Thionville	Metz
France	Chu Montpellier	Montpellier
France	Clinique Ambroise Pare	Nancy
France	Chu Nantes	Nantes
France	Chu Nimes	Nîmes
France	Chr D'Orleans	Orléans
France	Aphp Bichat	Paris
France	Php Hopital Europeen Georges Pompidou	Paris
France	Chu Reims	Reims
France	Chu Rennes	Rennes
France	Ch de Roubaix	Roubaix
France	Chu Rouen	Rouen
France	Chu Aphp Salpetriere	Saint-Denis
France	Clinique Cardiologique Du Nord Saint-Denis	Saint-Denis
France	Chu Saint-Etienne	Saint-Étienne
France	Chu Strasbourg	Strasbourg
France	Chu Toulouse	Toulouse
France	Clinique Pasteur Toulouse	Toulouse
France	Chu Tours Saint-Avertin	Tours
France	Hopital Nord Franche-Comte	Trévenans
France	CHRU de Nancy	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Mathieu ECHIVARD

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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]
Secondary	Rate of need to set-up left ventricular assist device (LVAD) or heart transplantation.		: 12 months and up to 7 years after ICD implantation
Secondary	Rate of all-cause death.		12 months and up to 7 years after ICD implantation
Secondary	Rate of hospitalization for heart failure worsening.		12 months and up to 7 years after ICD implantation
Secondary	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.		Frame: 12 months and up to 7 years after ICD implantation
Secondary	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