Clinical trial NCT03319160: LifeVest Safety and Efficacy in Real Life Settings in France
Official title: Post-market Clinical Follow-up Study Evaluating the Efficacy and Safety of LifeVest in Real-life Settings in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Cardiac Death
Left Ventricular Dysfunction
Cardiac Event
Cardiac Arrythmias
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2017-10-24
Enrollment: 1164
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Residents of France All patient who were prescribed a LifeVest were approached for consent. In addition to those prospectively enrolled, patients who had completed LifeVest use prior to the study start were eligible for retrospective enrollment.

Brief summary: This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.

Detailed description: LifeVest has obtained coverage for 4 indications: (i) implantable cardiac defibrillator (ICD) removal due to cardiac device infections, (ii) a bridge to heart transplantation, (iii) in the early post-myocardial infarction period with left ventricular (LV) dysfunction (LVEF \<30%), (iv) and a recent coronary revascularization with LV dysfunction (LVEF \< 30%). There is no current comparator to LifeVest. In France, patients at high risk for sudden cardiac arrest (SCD) and waiting for heart transplant or ICD are hospitalized or discharged home without any particular ECG monitoring. LifeVest has been demonstrated to automatically detect and terminate rapid ventricular arrhythmias. Introduction of LifeVest into the current patient management would definitely improve the clinical outcomes and benefit the patients with temporary risk of SCD. The use of LifeVest was shown to be effective in protecting patients against SCD in the United States. However, the clinical impact of using LifeVest in France remains unassessed. Therefore we are planning to conduct a post-market study in France to provide efficacy and safety data for the reimbursement dossier renewal before April 2017.

Eligibility criteria: Inclusion Criteria:

* Patients receiving a LifeVest prescription in clinical routine for the following indications:

  1. implantable cardiac defibrillator (ICD) removal due to cardiac device infections,
  2. a bridge to heart transplantation,
  3. in the early post-myocardial infarct (MI) period with left ventricular (LV) dysfunction (LVEF \<30%),
  4. a recent coronary revascularization with LV dysfunction (LVEF \< 30%).
* Patients who have given their consent to participate.

Exclusion Criteria:

- There are no exclusion criteria for this study

Primary outcomes:
measure: Appropriate Shock Events Per Patient
timeFrame: start to end of WCD use (3 months typical prescription)
measure: Risk of Not Receiving Appropriate Shocks When Necessary
timeFrame: from start to end of WCD use (3 months typical prescription)
measure: Inappropriate Shock Events Per Patient
timeFrame: from start to end of WCD use (3 months typical prescription)
Secondary outcomes:
measure: Survival During WCD Use
timeFrame: from start to end of WCD use (3 months typical prescription)
measure: Quality of Life Relative to Health State
timeFrame: Time of enrollment
Other outcomes:
measure: Causes of Mortality
timeFrame: Duration of prescribed device use, up to 3 months.
measure: Deaths While Wearing the WCD
timeFrame: Terminal event may have occurred any time during device use, up to 3 months. All data available up to 24 hours prior to the terminal event was used for adjudication.
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Toulouse
country: France
facility: Clinique PASTEUR
Study officials:
affiliation: Zoll Medical Corporation
name: Steve Szymkiewicz, MD
role: STUDY_DIRECTOR
References:
citation: Garcia R, Combes N, Defaye P, Narayanan K, Guedon-Moreau L, Boveda S, Blangy H, Bouet J, Briand F, Chevalier P, Cottin Y, Da Costa A, Degand B, Deharo JC, Eschalier R, Extramiana F, Goralski M, Guy-Moyat B, Guyomar Y, Hermida JS, Jourda F, Lellouche N, Mahfoud M, Manenti V, Mansourati J, Martin A, Pasquie JL, Ritter P, Rollin A, Tibi T, Yalioua A, Gras D, Sadoul N, Piot O, Leclercq C, Marijon E. Wearable cardioverter-defibrillator in patients with a transient risk of sudden cardiac death: the WEARIT-France cohort study. Europace. 2021 Jan 27;23(1):73-81. doi: 10.1093/europace/euaa268.