CompletedNot Applicable

LifeVest Safety and Efficacy in Real Life Settings in France

France1,164 participantsStarted 2017-02-02

Plain-language summary

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

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. implantable cardiac defibrillator (ICD) removal due to cardiac device infections,
✓. a bridge to heart transplantation,
✓. in the early post-myocardial infarct (MI) period with left ventricular (LV) dysfunction (LVEF \<30%),
✓. a recent coronary revascularization with LV dysfunction (LVEF \< 30%).

Appropriate Shock Events Per Patient

Timeframe: start to end of WCD use (3 months typical prescription)

Risk of Not Receiving Appropriate Shocks When Necessary

Timeframe: from start to end of WCD use (3 months typical prescription)

Inappropriate Shock Events Per Patient

Timeframe: from start to end of WCD use (3 months typical prescription)

NCT IDNCT03319160

SponsorZoll Medical Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-09-30

Results submitted2023-02-16