Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
500 participants
INTERVENTIONAL
2023-07-12
2030-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Encore PFO closure device
Encore PFO closure device
The Encore PFO closure device comprises an implant component and a single-use delivery system.
Any FDA-approved PFO closure device chosen by the investigator
FDA-approved PFO closure device
Chosen by the investigator
Interventions
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Encore PFO closure device
The Encore PFO closure device comprises an implant component and a single-use delivery system.
FDA-approved PFO closure device
Chosen by the investigator
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
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Bright Research Partners
INDUSTRY
Yale Cardiovascular Research Group
OTHER
Encore Medical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher D Nielsen, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ENC-CL-5000
Identifier Type: -
Identifier Source: org_study_id
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