Status:
ACTIVE_NOT_RECRUITING
Amplatzer PFO Occluder Post-marketing Surveillance Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
PFO - Patent Foramen Ovale
Eligibility:
All Genders
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 th...
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 ...
Eligibility Criteria
Inclusion
- Refer to Amplatzer PFO occluder IFU
Exclusion
- Refer to Amplatzer PFO occluder IFU
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 28 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04349995
Start Date
October 1 2019
End Date
May 28 2026
Last Update
November 1 2024
Active Locations (1)
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1
Abbott Medical Japan LLC
Mita, Minato, Japan, 108-6304