Skip to main content
OpenTrials
Completed

NCT Number: NCT05123885

Wearable Then Implantable Cardiac Defibrillator After Myocardial Infarction

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Amiens, Amiens, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Study on Data

Other

Study on Data

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.

    Time frame: 12 months after ICD implantation

Secondary 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.

    Time frame: Up to 7 years after ICD implantation

  2. 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]

  3. 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

  4. Rate of all-cause death.

    Time frame: 12 months and up to 7 years after ICD implantation

  5. Rate of hospitalization for heart failure worsening.

    Time frame: 12 months and up to 7 years after ICD implantation

  6. 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

  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, and mortality from any cause.

    Time frame: 12 months and up to 7 years after ICD implantation

Sponsors and collaborators

Lead sponsor

Mathieu ECHIVARD

Other

Registry information

Official study title

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

Acronym: WICD-MI

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 17, 2021
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.