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OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
Overall Recruitment Status: Enrollment complete
 
Official Title
OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
 
Region Sponsors
Northwest
Abbott Medical Devices
 
Acronym NCT No.
(PFO PAS) NCT03309332
 
Study Type Phase
INTERVENTIONAL
Phase IV
 
Purpose
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
 
Detailed Description
A maximum of 1214 adult subjects will be enrolled at up to 100 centers in the U.S. and Canada. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant.
 
 
 
Inclusion Criteria
  • Subjects with a PFO who have had an ischemic stroke within the last 547 days
 
Exclusion Criteria
  • Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a >50% lumen diameter supplying the involved lesion
  • Intra-cardiac thrombus or tumor
  • Documented evidence of venous thrombus in the vessels through which access to the PFO is gained
  • Acute or recent (within 6 months prior to consent) myocardial infarction or unstable angina
  • Left ventricular aneurysm or akinesis
  • Mitral valve stenosis or severe mitral regurgitation requiring intervention irrespective of etiology
  • Aortic valve stenosis (mean gradient >40 mmHg) or severe aortic valve regurgitation
  • Mitral or aortic valve vegetation or prosthesis
  • Aortic arch plaques protruding greater than 4mm into the aortic lumen
  • Left ventricular dilated cardiomyopathy with depressed left ventricular ejection fraction (LVEF less than 35%)
  • Please contact study team for additional inclusion/exclusion criteria
 
Keywords and/or Specific Medical Conditions
  • Cardiovascular Abnormalities
  • Heart Diseases
  • Cardiovascular Diseases
  • Heart Septal Defects
  • Congenital Abnormalities
  • Heart Septal Defects, Atrial
  • Foramen Ovale, Patent
  • Cardiology
  • Heart Defects, Congenital
 
KP Clinical Facility
  • Sunnyside Medical Center
 
Clinical Area
  • Cardiology


Principal Investigator:
Abhimanyu Uberoi, MD
Contact Information:
- Britt Ash, RN
-Sunnyside Medical Center


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