MedTrace Logo

Amplatzer PFO Occluder Post-marketing Surveillance Study

NCT04349995 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-11-01

No results posted yet for this study

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.

Conditions

  • PFO - Patent Foramen Ovale

Interventions

DEVICE

Amplatzer PFO Occluder

Percutaneous PFO closure using Amplatzer PFO Occluder

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-12-14
Completion
2026-05-28

Countries

  • Japan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04349995 on ClinicalTrials.gov