ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Recruiting
Observational Study
Sudden Cardiac Arrest
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 5,179 (estimated)
- Sponsor
- Kestra Medical Technologies, Inc. · Industry
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About This Trial
Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult patient prescribed the ASSURE wearable cardioverter defibrillator
* Provided written informed consent to participate in the ASSURE Patient Registry
Exclusion Criteria:
* Patients who do not meet the Inclusion criteria
Contacts