Encore PFO Closure Device - The PerFOrm Trial

Last updated: September 11, 2024
Sponsor: Encore Medical Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Blood Clots

Cerebral Ischemia

Stroke

Treatment

FDA-approved PFO closure device

Encore PFO closure device

Clinical Study ID

NCT05537753
ENC-CL-5000
  • Ages 18-60
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of PFO, defined as visualization of microbubbles per TEE in the leftatrium within three cardiac cycles from the right atrial opacification demonstratingright-to-left shunting at rest and/or during Valsalva release

  2. Cryptogenic stroke within the last 270 days; stroke is defined as acute focalneurological deficit, presumed to be due to focal ischemia, and confirmed by MRI orCT to be a new, neuroanatomically relevant cerebral infarct

Exclusion

Exclusion Criteria:

  1. Age <18 years and age >60 years

  2. Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels

  3. Intracardiac thrombus or tumor

  4. Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina

  5. Left ventricular aneurysm or akinesis

  6. Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitralregurgitation

  7. Aortic valve stenosis (gradient >40 mmHg) or severe aortic valve regurgitation

  8. Mitral or aortic valve vegetation or prosthesis

  9. Left ventricular ejection fraction <35%

  10. Other identifiable cause of stroke, including but not limited to aortic arch plaques (protruding >4 mm into the lumen), large artery atherosclerotic disease, anestablished cardioembolic source, small-vessel occlusive disease, or arterialdissection

  11. Evidence of a hypercoagulable disorder requiring anticoagulation therapy; thisdetermination will be based on the evaluation of: anticardiolipin antibody (Ab) ofthe IgG or IgM type, Lupus anticoagulant, B2-glycoprotein-1 Ab, and fasting plasmahomocysteine

  12. Another source of right-to-left shunts identified at baseline, including an atrialseptal defect and/or fenestrated septum

  13. Any history of atrial fibrillation/atrial flutter (chronic or intermittent)

  14. Active endocarditis or other untreated infections

  15. Chronic kidney disease stage 4 or higher or end-stage renal failure requiringdialysis (eGFR less than 30)

  16. Severe liver disease (ALT 3X ULN) or documented cirrhosis

  17. Lung disease requiring continuous home oxygen

  18. Uncontrolled hypertension, defined as sustained elevated blood pressure >160/90 mmHg on medication

  19. Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on mostrecent test which must have been collected within the last year)

  20. Anatomical or physiological structures that do not permit TEE

  21. Anticipated need for treatment of structural cardiac defects other than PFO

  22. Concomitant cardiac anomalies requiring an operative procedure

  23. Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis)

  24. Hypersensitivity to contrast medium or nickel

  25. Contraindication to aspirin or clopidogrel

  26. The required sheaths cannot be passed through the relevant vessels for access to thePFO

  27. Vulnerable patient (e.g., incarcerated or cognitively challenged adults); seeSection 7.2.1

  28. Subject is unable or unwilling to provide informed consent

  29. Subject is unable to comply with the protocol

  30. Any other clinical reasons for which the patient would not be an appropriatecandidate for the study, as determined by the site investigators

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: FDA-approved PFO closure device
Phase:
Study Start date:
July 12, 2023
Estimated Completion Date:
October 31, 2030

Study Description

This is a prospective, multicenter, randomized clinical study to determine the safety and effectiveness of the Encore PFO closure device, which is indicated for percutaneous, transcatheter closure of a patent foramen ovale (PFO) in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.

Connect with a study center

  • Arkansas Cardiology

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

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

    La Jolla, California 92037
    United States

    Active - Recruiting

  • University of South Florida

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Mercy One Iowa Heart Center

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Jackson Heart Clinic

    Jackson, Mississippi 39216
    United States

    Active - Recruiting

  • CHI Health

    Omaha, Nebraska 68124
    United States

    Active - Recruiting

  • Medical University of South Carolina Gazes Research Institute

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

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