Testing a new device for closing a heart defect related to stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of the Encore PFO closure device for patients with a patent foramen ovale (PFO) who have experienced a cryptogenic stroke. It is a multicenter, randomized clinical trial comparing the Encore device to any FDA-approved PFO closure device chosen by the investigator. The goal is to establish that the Encore device is safe and effective, providing noninferiority to existing options. Participants will undergo a percutaneous, transcatheter procedure to close the PFO.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of PFO, defined as visualization of microbubbles per TEE in the left atrium within three cardiac cycles from the right atrial opacification demonstrating right-to-left shunting at rest and/or during Valsalva release
2. Cryptogenic stroke within the last 270 days; stroke is defined as acute focal neurological deficit, presumed to be due to focal ischemia, and confirmed by MRI or CT to be a new, neuroanatomically relevant cerebral infarct

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 mitral regurgitation
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, an established cardioembolic source, small-vessel occlusive disease, or arterial dissection
11. Evidence of a hypercoagulable disorder requiring anticoagulation therapy; this determination will be based on the evaluation of: anticardiolipin antibody (Ab) of the IgG or IgM type, Lupus anticoagulant, B2-glycoprotein-1 Ab, and fasting plasma homocysteine
12. Another source of right-to-left shunts identified at baseline, including an atrial septal 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 requiring dialysis (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 mm Hg on medication
19. Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent 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 the PFO
27. Vulnerable patient (e.g., incarcerated or cognitively challenged adults); see Section 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 appropriate candidate for the study, as determined by the site investigators

Where it's running

• Arkansas Cardiology
  Little Rock, Arkansas, United States Recruiting
• Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital
  La Jolla, California, United States Recruiting
• University of South Florida
  Tampa, Florida, United States Recruiting
• Mercy One Iowa Heart Center
  West Des Moines, Iowa, United States Recruiting
• Kansas University Medical Center
  Kansas City, Kansas, United States Recruiting
• Jackson Heart Clinic
  Jackson, Mississippi, United States Recruiting

Study contacts

• Principal investigator: Christopher D Nielsen, MD — Medical University of South Carolina
• Study coordinator: Joseph Marino
• Email: jmarino@encore-medical.com
• Phone: 651-797-0913

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-term outcomes after PFO closure at Severance Hospital

  This registry tests how well percutaneous PFO closure works over the long term and what factors predict residual shunt, new atrial fibrillation, or other outcomes in adults who had the procedure.

  Recruiting Yonsei University · Seoul · NCT07724171

• P3 Occluder System for closing a heart opening (PFO) after stroke

  We are testing the P3 Occluder System to see if it safely and effectively closes a patent foramen ovale in adults who had a stroke related to their heart opening.

  Recruiting Recross Cardio, Inc. · Belgrade · NCT07698951

• Percutaneous repair of the atrial septum using the P3 Occluder System for PFO closure

  This trial tests the P3 Occluder System to close a patent foramen ovale (PFO) in adults 18–65 who have had a stroke that may be linked to their PFO.

  Recruiting at 5 sites Recross Cardio, Inc. · Los Angeles, California and 4 other locations · NCT07172464

• Transcatheter closure versus medical therapy for PFO in older adults

  This tests whether closing a patent foramen ovale (PFO) with a catheter plus usual medicines prevents another unexplained (cryptogenic) stroke in people over 60 better than medicines alone.

  Recruiting Institut universitaire de cardiologie et de pneumologie de Québec, University Laval · Québec, Quebec and 1 other locations · NCT05907694

• Evaluating Cera™ devices for closing heart openings in stroke patients

  This study is testing a new device to see if it can safely close heart openings in stroke patients and work as well as other options available.

  Recruiting at 7 sites Lifetech Scientific (Shenzhen) Co., Ltd. · Beijing, Beijing Municipality and 13 other locations · NCT05774288

• PFO-Directed Therapy for Migraines: Closing the Hole or Using a Blood Thinner

  This study tests whether closing a patent foramen ovale (PFO) plus 24 weeks of prasugrel works better for long-term migraine relief than prasugrel alone in people whose migraines improve on blood-thinning therapy.

  Recruiting Phase 3 Columbia University · New York, New York · NCT07629635

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.