AMPLATZER PFO
AMPLATZER PFO Occluder Post Approval Study
-
Clinical Trial Information
Trial Contact: Marquart, Vashnie; Ngo, George M.; Cox, Caitlin L
Trial Phone: 321-843-1037 ; 3218439657 ; 321-841-1505
-
IRB No: 17.124.10
Protocol Abbrev: AMPLATZER PFO
Principal Investigator: Vijaykumar S Kasi, MD, PhD
Phase: Device: Category N/A
Age Group: Adult
Secondary Protocol No: CRD_806
Treatment: DEVICE: AMPLATZER PFO Occluder
Therapies Involved: Procedural
ClinicalTrials.gov ID: NCT03309332
-
Objective
Assessing the 30-day rate of device- or procedure-related serious adverse events including those that led to death. And to demonstrate that the AMPLATZERTM PFO Occluder is effective by assessing the rate of recurrent ischemic stroke through 5 years.
-
Key Eligibility
1. History of PFO
2. CVA within 270 days
3. Cryptogenic Stroke
