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ACTIVE NOT RECRUITING
NCT04349995

Amplatzer PFO Occluder Post-marketing Surveillance Study

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2019-10-01

Completion Date

2026-05-28

Last Updated

2024-11-01

Healthy Volunteers

No

Interventions

DEVICE

Amplatzer PFO Occluder

Percutaneous PFO closure using Amplatzer PFO Occluder

Locations (1)

Abbott Medical Japan LLC

Mita, Minato, Japan