N/A
Completed N=1,164
LifeVest Safety and Efficacy in Real Life Settings in France
Sudden Cardiac Death · left ventricular dysfunction · Cardiac Event · Cardiac Arrythmias
Source: ClinicalTrials.gov NCT03319160 ↗
Enrolled (actual)
1,164
Serious AEs
0.5%
Results posted
Dec 2024
Primary outcomePrimary: Appropriate Shock Events Per Patient — 1139; 17; 1 Participants
Summary
This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Appropriate Shock Events Per Patient |
1139; 17; 1 | — |
| PRIMARY Risk of Not Receiving Appropriate Shocks When Necessary |
19; 15; 8 | — |
| PRIMARY Inappropriate Shock Events Per Patient |
1149; 8 | — |
| SECONDARY Survival During WCD Use |
1132; 25; 1 | — |
| SECONDARY Quality of Life Relative to Health State |
1.96; 2.17; 2.51; 2.11; 2.35; 1.66 | — |
Eligibility Criteria
Inclusion Criteria
- Patients receiving a LifeVest prescription in clinical routine for the following indications:
- 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%).
- Patients who have given their consent to participate.
Exclusion Criteria
- There are no exclusion criteria for this study
Data sourced from ClinicalTrials.gov (NCT03319160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.