Post-market clinical follow-up study evaluating the efficacy and safety of the wearable cardioverter-defibrillator (WCD) medical device 'LifeVest' in real-life settings in France
Completed
- Conditions
- Sudden cardiac death (SCD)Circulatory System
- Registration Number
- ISRCTN91372291
- Lead Sponsor
- ZO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 550
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method