Encore PFO Closure Device - The PerFOrm Trial
Recruiting now · Not applicable
Conditions studied: Patent Foramen Ovale, Cryptogenic Stroke
In brief
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.
Key facts
- Study ID
- NCT05537753
- Run by
- Encore Medical Inc.
- People needed
- 500
- Starts
- 2023-07-12
- Expected to finish
- 2030-10-01
- Last updated by the study team
- 2024-09-19
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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
You may not qualify if…
- Age <18 years and age >60 years
- Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels
- Intracardiac thrombus or tumor
- Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina
- Left ventricular aneurysm or akinesis
- Mitral valve stenosis (mitral valve area less than 1.5cm2) or severe mitral regurgitation
- Aortic valve stenosis (gradient >40 mmHg) or severe aortic valve regurgitation
- Mitral or aortic valve vegetation or prosthesis
- Left ventricular ejection fraction <35%
- 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
- 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
- Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum
- Any history of atrial fibrillation/atrial flutter (chronic or intermittent)
- Active endocarditis or other untreated infections
- Chronic kidney disease stage 4 or higher or end-stage renal failure requiring dialysis (eGFR less than 30)
- Severe liver disease (ALT 3X ULN) or documented cirrhosis
- Lung disease requiring continuous home oxygen
- Uncontrolled hypertension, defined as sustained elevated blood pressure >160/90 mm Hg on medication
- Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent test which must have been collected within the last year)
- Anatomical or physiological structures that do not permit TEE
- Anticipated need for treatment of structural cardiac defects other than PFO
- Concomitant cardiac anomalies requiring an operative procedure
- Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis)
- Hypersensitivity to contrast medium or nickel
- Contraindication to aspirin or clopidogrel
Where it is running
- Arkansas Cardiology — Little Rock, Arkansas, United States (enrolling)
- Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital — La Jolla, California, United States (enrolling)
- University of South Florida — Tampa, Florida, United States (enrolling)
- Mercy One Iowa Heart Center — West Des Moines, Iowa, United States (enrolling)
- Kansas University Medical Center — Kansas City, Kansas, United States (enrolling)
- Jackson Heart Clinic — Jackson, Mississippi, United States (enrolling)
- CHI Health — Omaha, Nebraska, United States (enrolling)
- Medical University of South Carolina Gazes Research Institute — Charleston, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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