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Encore PFO Closure Device - The PerFOrm Trial
NCT05537753 · View on ClinicalTrials.gov ↗
Study Summary
The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.
Conditions Studied
Interventions
- DEVICE Encore PFO closure device
- DEVICE FDA-approved PFO closure device
Study Locations (8)
Arkansas
- Arkansas Cardiology — Little Rock
California
- Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital — La Jolla
Florida
- University of South Florida — Tampa
Iowa
- Mercy One Iowa Heart Center — West Des Moines
Kansas
- Kansas University Medical Center — Kansas City
Mississippi
- Jackson Heart Clinic — Jackson
Nebraska
- CHI Health — Omaha
South Carolina
- Medical University of South Carolina Gazes Research Institute — Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2023-07-12 |
| Est. Completion | 2030-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05537753
The ClinicalTrials.gov registry entry for NCT05537753 describes a study currently listed as recruiting. It is categorized as NA, 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 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Encore Medical, 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 2 conditions, with Patent Foramen Ovale appearing as the primary indexed condition, and to 2 interventions — of which Encore PFO closure device 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: NCT05537753 reports 8 study locations spanning 8 distinct geographic areas — top geographies include Arkansas, California, Florida. 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 NCT05537753 about?
NCT05537753 is a clinical study titled "Encore PFO Closure Device - The PerFOrm Trial". The objective of this study is to establish reasonable assurance of safety, effectiveness, and noninferiority of the Encore PFO closure device when compared to any investigator chosen FDA-approved PFO closure device.
What is the current status of trial NCT05537753?
This trial is currently recruiting. It is a NA study. The enrollment target is 500 participants. The study started on 2023-07-12. Estimated completion is 2030-10.
What conditions does trial NCT05537753 study?
This clinical trial studies the following conditions: Patent Foramen Ovale, Cryptogenic Stroke. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05537753?
The interventions under investigation include: Encore PFO closure device (DEVICE), FDA-approved PFO closure device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05537753?
This trial is sponsored by Encore Medical, 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 NCT05537753 being conducted?
This trial has 8 study locations across Arkansas, California, Florida, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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