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Clinical Trials/ISRCTN91372291
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.

Registry
who.int
Start Date
January 29, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ZO

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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