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NCT05537753 · ClinicalTrials.gov registry record · NA
Encore PFO Closure Device - The PerFOrm Trial
A NA study of Patent Foramen Ovale and Cryptogenic Stroke, sponsored by Encore Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 500
- Enrollment target
- 8
- Study locations
NCT05537753: Recruiting NA study of Patent Foramen Ovale and Cryptogenic Stroke, sponsored by Encore Medical.
NCT05537753 is a NA study of Patent Foramen Ovale and Cryptogenic Stroke that is actively recruiting participants, run by Encore Medical. The registered enrollment target is 500 participants, above the 350-participant average among 7 other Patent Foramen Ovale trials with a reported enrollment target (43% higher). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05537753, a NA study of Patent Foramen Ovale and Cryptogenic Stroke, is actively recruiting participants, sponsored by Encore Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 500 participants
- Enrollment target
- 8
- Study locations
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 |
What NCT05537753 shows while recruiting
NCT05537753 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 350-participant average among 7 other Patent Foramen Ovale trials with a reported enrollment target (43% higher).
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.
NCT05537753 lists 8 locations in 8 states (Arkansas, California, Florida).
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.
What interventions are being tested in trial NCT05537753?
The interventions under investigation include: Encore PFO closure device (DEVICE), FDA-approved PFO closure device (DEVICE).
Who is sponsoring clinical trial NCT05537753?
This trial is sponsored by Encore Medical, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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