Status:
COMPLETED
LifeVest Safety and Efficacy in Real Life Settings in France
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Sudden Cardiac Death
Left Ventricular Dysfunction
Eligibility:
All Genders
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-...
Eligibility Criteria
Inclusion
- 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
- \- There are no exclusion criteria for this study
Key Trial Info
Start Date :
February 2 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 30 2019
Estimated Enrollment :
1164 Patients enrolled
Trial Details
Trial ID
NCT03319160
Start Date
February 2 2017
End Date
March 30 2019
Last Update
December 9 2024
Active Locations (2)
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1
Hôpital Européen Georges Pompidou
Paris, France
2
Clinique PASTEUR
Toulouse, France