Amplatzer PFO Occluder Post-marketing Surveillance Study

NCT ID: NCT04349995

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2026-05-28

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").

Conditions

PFO - Patent Foramen Ovale

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Amplatzer PFO Occluder

Percutaneous PFO Closure using Amplatzer PFO occluder

Amplatzer PFO Occluder

Intervention Type: DEVICE

Percutaneous PFO closure using Amplatzer PFO Occluder

Interventions

Amplatzer PFO Occluder

Percutaneous PFO closure using Amplatzer PFO Occluder

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Refer to Amplatzer PFO occluder IFU

Exclusion Criteria

• Refer to Amplatzer PFO occluder IFU

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Abbott Medical Japan LLC

Mita, Minato, Japan

Countries

Japan

Other Identifiers

ABT-CIP-10278

Identifier Type: -

Identifier Source: org_study_id