NCT04349995

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Oct 2019May 2026

Study Start

First participant enrolled

October 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2026

Expected
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

3.2 years

First QC Date

April 14, 2020

Last Update Submit

October 30, 2024

Conditions

PFO - Patent Foramen Ovale

Outcome Measures

Primary Outcomes (3)

  • device- or procedure related SAE rate

    device- or procedure related serious adverse events (SAEs) through 30 days

    up to 30 Days

  • PE, DVT and ischemic stroke and atrial fibrillation rate

    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

    Effective closure of the PFO at 1 year

    At 1 year

Study Arms (1)

Amplatzer PFO Occluder

Percutaneous PFO Closure using Amplatzer PFO occluder

Device: Amplatzer PFO Occluder

Interventions

Amplatzer PFO OccluderDEVICE

Percutaneous PFO closure using Amplatzer PFO Occluder

Amplatzer PFO Occluder

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Refer to Amplatzer PFO occluder IFU

You may not qualify if:

  • Refer to Amplatzer PFO occluder IFU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abbott Medical Japan LLC

Mita, Minato, 108-6304, Japan

Location

MeSH Terms

Conditions

Foramen Ovale, Patent

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 16, 2020

Study Start

October 1, 2019

Primary Completion

December 14, 2022

Study Completion (Estimated)

May 28, 2026

Last Updated

November 1, 2024

Record last verified: 2024-10

Locations

JP(1)