Encore PFO Closure Device - The PerFOrm Trial
- Conditions
- Patent Foramen OvaleCryptogenic Stroke
- Interventions
- Device: FDA-approved PFO closure deviceDevice: Encore PFO closure device
- Registration Number
- NCT05537753
- Lead Sponsor
- Encore Medical Inc.
- 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 closure device.
- 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 a patent foramen ovale (PFO) in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Any FDA-approved PFO closure device chosen by the investigator FDA-approved PFO closure device - Encore PFO closure device Encore PFO closure device -
- Primary Outcome Measures
Name Time Method Safety: The incidence of device- or procedure-related serious adverse events (SAEs) 6 months Effectiveness: Effective closure 6 months Defined as shunt grade 0 or I while at rest and during Valsalva as assessed by transesophageal echocardiography (TEE) and bubble study as adjudicated by the echocardiographic core laboratory
- Secondary Outcome Measures
Name Time Method Occurrence of procedural success Procedural Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death 5 years Complete closure 6 months Defined as shunt grade 0 while at rest and during Valsalva as assessed by TEE and bubble study as adjudicated by the echocardiographic core laboratory
Occurrence of transient ischemic attacks (TIA) 5 years Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation) 5 years Occurrence of technical success Procedural
Trial Locations
- Locations (8)
Medical University of South Carolina Gazes Research Institute
🇺🇸Charleston, South Carolina, United States
Arkansas Cardiology
🇺🇸Little Rock, Arkansas, United States
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial Hospital
🇺🇸La Jolla, California, United States
Mercy One Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
CHI Health
🇺🇸Omaha, Nebraska, United States
University of South Florida
🇺🇸Tampa, Florida, United States