NCT05135403 ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
| NCT ID | NCT05135403 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kestra Medical Technologies, Inc. |
| Condition | Sudden Cardiac Arrest |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,179 participants |
| Start Date | 2021-11-20 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,179 participants in total. It began in 2021-11-20 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Jeanne Poole, M.D.
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05135403 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sudden Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05135403 currently recruiting?
Yes, NCT05135403 is actively recruiting participants. Contact the research team at kristin.eis@kestramedical.com for enrollment information.
Where is the NCT05135403 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT05135403 clinical trial?
NCT05135403 is sponsored by Kestra Medical Technologies, Inc.. The principal investigator is Jeanne Poole, M.D. at University of Washington. The trial plans to enroll 5,179 participants.