Tests the Encore device for closing a heart hole in adults
Tests the Encore device against approved devices for patent foramen ovale in adults.
Plain-language title generated from the registry record
Registry title: Encore PFO Closure Device - The PerFOrm Trial
Key facts
- Where
- Charleston, Jackson, Kansas City, La Jolla, Little Rock, Omaha, Tampa, and West Des Moines, United StatesSee the 8 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT05537753, who can take part
Where in United States
- Medical University of South Carolina Gazes Research InstituteCharleston, United StatesTaking people
- Jackson Heart ClinicJackson, United StatesTaking people
- Kansas University Medical CenterKansas City, United StatesTaking people
- Southern CA Permanente Medical Group - Kaiser San Diego and Scripps Memorial HospitalLa Jolla, United StatesTaking people
- Arkansas CardiologyLittle Rock, United StatesTaking people
- CHI HealthOmaha, United StatesTaking people
- University of South FloridaTampa, United StatesTaking people
- Mercy One Iowa Heart CenterWest Des Moines, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Encore Medical Inc.
- Trial code
- NCT05537753
- Record updated
- 19 September 2024
- Original description
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.Read full original descriptionShow less
Encore PFO Closure Device U.S. IDE Randomized Trial - The PerFOrm Trial
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.
Inclusion: 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: Concomitant cardiac anomalies requiring an operative procedure; Acute or recent (within 6 months) myocardial infarction (MI) or unstable angina; 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; Any history of atrial fibrillation/atrial flutter (chronic or intermittent); Active endocarditis or other untreated infections; Lung disease requiring continuous home oxygen; Uncontrolled hypertension, defined as sustained elevated blood pressure >160/90 mm Hg on medication; Anticipated need for treatment of structural cardiac defects other than PFO; Hemorrhagic diseases (e.g., coagulopathy, tendency to hemolysis); Hypersensitivity to contrast medium or nickel; Left ventricular ejection fraction <35%; 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; Uncontrolled diabetes mellitus, defined as HbA1c greater than 9 (based on most recent test which must have been collected within the last year); Age <18 years and age >60 years; Greater than 50% lumen diameter stenosis of intracranial or extracranial vessels; Intracardiac thrombus or tumor; 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; Another source of right-to-left shunts identified at baseline, including an atrial septal defect and/or fenestrated septum; Anatomical or physiological structures that do not permit TEE; 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.