Long-term Procedural and Device Related Complications of PFO Closure

May 13, 2024 updated by: yinchunlin, Xuanwu Hospital, Beijing
We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

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

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • All patients who underwent PFO closure

Exclusion Criteria:

  • Unable to complete or adhere to the study

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ischemic stroke, Hemorrhagic stroke or transient ischemic attack
Time Frame: 1 month, 6 months, 1 year, 3 years, 5 years
1 month, 6 months, 1 year, 3 years, 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
atrial fibrillation
Time Frame: 1 month, 6 months, 1 year, 3 years, 5 years
1 month, 6 months, 1 year, 3 years, 5 years
Hemorrhage related to the use of antithrombotic drugs
Time Frame: 1 month, 6 months, 1 year, 3 years, 5 years
1 month, 6 months, 1 year, 3 years, 5 years
residual leaks
Time Frame: 1 month, 6 months, 1 year, 3 years, 5 years
1 month, 6 months, 1 year, 3 years, 5 years
death
Time Frame: 1 month, 6 months, 1 year, 3 years, 5 years
1 month, 6 months, 1 year, 3 years, 5 years
open-heart surgery
Time Frame: 1 month, 6 months, 1 year, 3 years, 5 years
1 month, 6 months, 1 year, 3 years, 5 years
Other severe events related to PFO closure
Time Frame: 1 month, 6 months, 1 year, 3 years, 5 years
1 month, 6 months, 1 year, 3 years, 5 years

Collaborators and Investigators

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

Sponsor

Xuanwu Hospital, Beijing

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 (Estimated)

May 30, 2024

Primary Completion (Estimated)

May 30, 2029

Study Completion (Estimated)

May 30, 2029

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 14, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yinchunlin_PFO safety

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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 Patent Foramen Ovale

Clinical Trials on PFO closure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe