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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05123885
Other study ID # 2021PI163
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


Related Conditions & MeSH terms


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
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