HVP_Amplatzer PFO PAS

HVP AMPLATZERâ„¢ PFO Occluder Post Approval Study

The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZERâ„¢ PFO Occluder in the post Approval Setting.

Key Inclusion Criteria:

1. Subjects with a PFO who have had an ischemic stroke within the last 270 days

Key Exclusion Criteria:

1. Atherosclerosis or other arteriopathy of the intracranial and extracranial vessels associated with a > 50% lumen diameter supplying the involved lesion
2. Intra-cardiac thrombus or tumor
3. Documented evidence of venous thrombus in the vessels through which access to the PFO is gained
4. Acute or recent (within 6 months prior to consent) myocardial infarction or unstable angina
5. Left ventricular aneurysm or akinesis
6. Mitral valve stenosis or severe mitral regurgitation requiring intervention irrespective of etiology
7. Aortic valve stenosis (mean gradient >40 mmHg) or severe aortic valve regurgitation
Mitral or aortic valve vegetation or prosthesis
8. Aortic arch plaques protruding greater than 4mm into the aortic lumen
9. Left ventricular dilated cardiomyopathy with depressed left ventricular ejection fraction (LVEF less than 35%)

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
N/A
NCT03309332
Heart and Vascular, Neurosciences
Interventional Cardiology
Ethan Korngold MD
Abbott Laboratories
Angela Redd
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center
  • TOC Gateway - Heart Clinic