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ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
NCT05135403 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Defibrillation
Study Locations (1)
Washington
- University of Washington Medical Center — Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,179 participants |
| Start Date | 2021-11-20 |
| Est. Completion | 2025-10-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05135403
The ClinicalTrials.gov registry entry for NCT05135403 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5,179 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kestra Medical Technologies, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Sudden Cardiac Arrest appearing as the primary indexed condition, and to 1 intervention — of which Defibrillation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05135403 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05135403 about?
NCT05135403 is a clinical study titled "ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)". 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.
What is the current status of trial NCT05135403?
This trial is currently recruiting. The enrollment target is 5,179 participants. The study started on 2021-11-20. Estimated completion is 2025-10-01.
What conditions does trial NCT05135403 study?
This clinical trial studies the following conditions: Sudden Cardiac Arrest. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05135403?
The interventions under investigation include: Defibrillation (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05135403?
This trial is sponsored by Kestra Medical Technologies, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05135403 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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