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LifeVest Safety and Efficacy in Real Life Settings in France

NCT ID: NCT03319160

Last Updated: 2024-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1164 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-02

Study Completion Date

2019-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Sudden Cardiac Death Left Ventricular Dysfunction Cardiac Event Cardiac Arrythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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All LifeVest Users

Patients who were prescribed and used a LifeVest in France

Wearable Cardioverter Defibrillator

Intervention Type DEVICE

A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention

Interventions

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Wearable Cardioverter Defibrillator

A non-invasive wearable cardioverter defibrillator detects and treats VT/VF without the need for bystander intervention

Intervention Type DEVICE

Other Intervention Names

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LifeVest

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Szymkiewicz, MD

Role: STUDY_DIRECTOR

Zoll Medical Corporation

Locations

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Hôpital Européen Georges Pompidou

Paris, , France

Site Status

Clinique PASTEUR

Toulouse, , France

Site Status

Countries

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France

References

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Garcia R, Warming PE, Narayanan K, Defaye P, Guedon-Moreau L, Blangy H, Piot O, Leclercq C, Marijon E; WEARIT-France Investigators. Dynamic changes in nocturnal heart rate predict short-term cardiovascular events in patients using the wearable cardioverter-defibrillator: from the WEARIT-France cohort study. Europace. 2023 May 19;25(5):euad062. doi: 10.1093/europace/euad062.

Reference Type DERIVED
PMID: 37021342 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33257972 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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90D0130

Identifier Type: -

Identifier Source: org_study_id