Status:
RECRUITING
Encore PFO Closure Device - The PerFOrm Trial
Lead Sponsor:
Encore Medical Inc.
Collaborating Sponsors:
Bright Research Partners
Yale Cardiovascular Research Group
Conditions:
Patent Foramen Ovale
Cryptogenic Stroke
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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...
Detailed 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 ...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- The required sheaths cannot be passed through the relevant vessels for access to the PFO
- Vulnerable patient (e.g., incarcerated or cognitively challenged adults); see Section 7.2.1
- Subject is unable or unwilling to provide informed consent
- Subject is unable to comply with the protocol
- Any other clinical reasons for which the patient would not be an appropriate candidate for the study, as determined by the site investigators
Key Trial Info
Start Date :
July 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05537753
Start Date
July 12 2023
End Date
October 1 2030
Last Update
September 19 2024
Active Locations (8)
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1
Arkansas Cardiology
Little Rock, Arkansas, United States, 72205
2
Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital
La Jolla, California, United States, 92037
3
University of South Florida
Tampa, Florida, United States, 33606
4
Mercy One Iowa Heart Center
West Des Moines, Iowa, United States, 50266