Amplatzer PFO Occluder Post-marketing Surveillance Study (PFO PMS Jpn)

June 6, 2023 updated by: Abbott Medical Devices
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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").

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Minato
      • Mita, Minato, Japan, 108-6304
        • Abbott Medical Japan LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients will be considered registered upon insertion of the Amplatzer PFO Occluder delivery system into the body

Description

Inclusion Criteria:

  • Refer to Amplatzer PFO occluder IFU

Exclusion Criteria:

  • Refer to Amplatzer PFO occluder IFU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Amplatzer PFO Occluder
Percutaneous PFO Closure using Amplatzer PFO occluder
Device: Amplatzer PFO Occluder
Percutaneous PFO closure using Amplatzer PFO Occluder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
device- or procedure related SAE rate
Time Frame: up to 30 Days
device- or procedure related serious adverse events (SAEs) through 30 days
up to 30 Days
PE, DVT and ischemic stroke and atrial fibrillation rate
Time Frame: 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
beyond 30 days through 3 years
Effective PFO closure
Time Frame: At 1 year
Effective closure of the PFO at 1 year
At 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Estimated)

January 30, 2024

Study Completion (Estimated)

May 28, 2026

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

June 8, 2023

Last Update Submitted That Met QC Criteria

June 6, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PFO - Patent Foramen Ovale

Clinical Trials on Amplatzer PFO Occluder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe