NCT06413147

Brief Summary

We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
37mo left

Started May 2024

Longer than P75 for all trials

Status
not yet 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 Progress39%
May 2024May 2029

First Submitted

Initial submission to the registry

May 8, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

May 30, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2029

Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

5 years

First QC Date

May 8, 2024

Last Update Submit

May 13, 2024

Conditions

Patent Foramen Ovale

Outcome Measures

Primary Outcomes (1)

  • ischemic stroke, Hemorrhagic stroke or transient ischemic attack

    1 month, 6 months, 1 year, 3 years, 5 years

Secondary Outcomes (6)

  • atrial fibrillation

    1 month, 6 months, 1 year, 3 years, 5 years

  • Hemorrhage related to the use of antithrombotic drugs

    1 month, 6 months, 1 year, 3 years, 5 years

  • residual leaks

    1 month, 6 months, 1 year, 3 years, 5 years

  • death

    1 month, 6 months, 1 year, 3 years, 5 years

  • open-heart surgery

    1 month, 6 months, 1 year, 3 years, 5 years

  • +1 more secondary outcomes

Interventions

PFO closureDEVICE

Surgery of PFO closure

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent PFO closure and willing to participate in this study.

You may qualify if:

  • All patients who underwent PFO closure

You may not qualify if:

  • Unable to complete or adhere to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Central Study Contacts

Chunlin Yin

CONTACT

13552566227yinclmail@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Xuanwu Hospital, Capital Medical University

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 14, 2024

Study Start

May 30, 2024

Primary Completion (Estimated)

May 30, 2029

Study Completion (Estimated)

May 30, 2029

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share