Encore PFO Closure Device - The PerFOrm Trial

Launched by ENCORE MEDICAL INC. · Sep 8, 2022

Keywords

ClinConnect Summary

The PerFOrm Trial is a clinical study that aims to evaluate a new device called the Encore PFO closure device. This device is designed to treat a condition known as Patent Foramen Ovale (PFO), which is a small opening in the heart that can contribute to strokes, specifically cryptogenic strokes—those that don't have a clear cause. The trial is looking to determine if the Encore device is safe and effective, and if it works just as well as other approved devices currently used for this purpose.

To be eligible for the trial, participants need to be between the ages of 65 and 74, and must have been diagnosed with a PFO and experienced a cryptogenic stroke within the last 270 days. Participants will undergo a process to ensure they meet specific health criteria, as certain medical conditions may exclude them from the study. Those who join can expect to receive close monitoring during the trial and help contribute to vital research that could improve stroke treatment options in the future.

Gender

ALL

Eligibility criteria

• 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