RecruitingPatent Foramen OvaleCryptogenic Stroke
Encore PFO Closure Device - The PerFOrm Trial
Eligible age
18–60 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Encore Medical Inc.
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Arkansas
Little Rock
California
La Jolla
Florida
Tampa
Iowa
West Des Moines
Kansas
Kansas City
Mississippi
Jackson
Nebraska
Omaha
South Carolina
Charleston
Source: ClinicalTrials.gov · NCT05537753 · last updated 2024-09-19