Cardiovascular Research Institute of Kansas, LLC | Wichita, KS
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About
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.
Full 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.
Enrollment
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Inclusion criteria
• Subjects with a PFO who have had an ischemic stroke within the last 547 days
Exclusion criteria
Liver failure: Liver enzymes outside the normal reference range for the laboratory at the investigational site: poor liver function as assessed by elevated PT (above the normal reference range for the laboratory at the investigational site) and low total protein and albumin (below the normal reference range for the laboratory at the investigational site).
Lung failure: Respiratory failure is retention of carbon dioxide more than 60 mmHg, poor oxygenation with oxygen tension less than 40 mmHg in room air or the need for assisted ventilation.
Primary purpose
Allocation
Interventional model
Masking
1,214 participants in 1 patient group
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Central trial contact
Maren Wagner
Data sourced from clinicaltrials.gov
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