ISRCTN91372291
Completed
Not Applicable
Post-market clinical follow-up study evaluating the efficacy and safety of LifeVest in real-life settings in France
ZO0 sites550 target enrollmentJanuary 29, 2016
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ZO
- Enrollment
- 550
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients receiving a LifeVest prescription in clinical routine. The following indications are authority approved:
- •1\. Implantable cardiac defibrillator (ICD) removal due to cardiac device infections
- •2\. A bridge to heart transplantation
- •3\. In the early post\-MI period with left ventricular (LV) dysfunction (LVEF \<30%)
- •4\. Recent coronary revascularization with LV dysfunction (LVEF \< 30%)
Exclusion Criteria
- •Patients who are physically or mentally unable to handle and use the WCD device appropriately, as judged by their responsible physician.
Outcomes
Primary Outcomes
Not specified
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