RecruitingNot ApplicableNCT05537753

Encore PFO Closure Device - The PerFOrm Trial

Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial

Sponsor

Encore Medical Inc.

Enrollment

500 participants

Start Date

Jul 12, 2023

Study Type

INTERVENTIONAL

Conditions

Cryptogenic Stroke Patent foramen ovale

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.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Encore PFO closure device and FDA-approved PFO closure device for people with cryptogenic stroke and patent foramen ovale. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEncore PFO closure device

The Encore PFO closure device comprises an implant component and a single-use delivery system.

DEVICEFDA-approved PFO closure device

Chosen by the investigator

Locations(8)

Arkansas Cardiology

Little Rock, Arkansas, United States

Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital

La Jolla, California, United States

University of South Florida

Tampa, Florida, United States

Mercy One Iowa Heart Center

West Des Moines, Iowa, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

CHI Health

Omaha, Nebraska, United States

Medical University of South Carolina Gazes Research Institute

Charleston, South Carolina, United States

View Full Details on ClinicalTrials.gov

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NCT05537753

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