Amplatzer PFO Occluder Post-marketing Surveillance Study
- Conditions
- PFO - Patent Foramen Ovale
- Registration Number
- NCT04349995
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
The purpose of the Amplatzer PFO Occluder post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
- Detailed Description
Based on the Ministerial Ordinance on Good Post-marketing Study Practice for Medical Device, the Surveillance will register patients with patent foramen ovale (PFO) who have experienced a PFO-related cryptogenic cerebral infarction (including diagnosed paradoxical cerebral embolism) or transient ischemic attack (determined by positive head imaging such as DWI) in whom an Amplatzer PFO Occluder implant was attempted (Marketing Approval No. 30100BZX00024000, date May 28, 2019, hereinafter referred to as "PFO occluder").
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Refer to Amplatzer PFO occluder IFU
- Refer to Amplatzer PFO occluder IFU
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PE, DVT and ischemic stroke and atrial fibrillation rate beyond 30 days through 3 years rate of pulmonary embolism (PE), deep vein thrombosis (DVT), ischemic stroke and atrial fibrillation beyond 30 days through 3 years
Effective PFO closure At 1 year Effective closure of the PFO at 1 year
device- or procedure related SAE rate up to 30 Days device- or procedure related serious adverse events (SAEs) through 30 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Abbott Medical Japan LLC
🇯🇵Mita, Minato, Japan
Abbott Medical Japan LLC🇯🇵Mita, Minato, Japan