Cryptogenic Stroke, Patent Foramen Ovale
Conditions
Keywords
PFO closure, Stroke
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.
Interventions
DEVICEEncore PFO closure device
The Encore PFO closure device comprises an implant component and a single-use delivery system.
DEVICEFDA-approved PFO closure device
Chosen by the investigator
Sponsors
Bright Research Partners
Yale Cardiovascular Research Group
Encore Medical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of transient ischemic attacks (TIA) | 5 years | — |
| Occurrence of clinically significant new atrial arrhythmia (including atrial fibrillation) | 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 procedural success | Procedural | — |
| Occurrence of technical success | Procedural | — |
| Occurrence of recurrent symptomatic cryptogenic non-fatal stroke or cardiovascular death | 5 years | — |
Countries
United States
Contacts
Primary ContactJoseph Marino
Backup ContactHannah Bearinger
Outcome results
None listed