Long-term Procedural and Device Related Complications of PFO Closure

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

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Trial opening soon.

Key information

Conditions

Patent Foramen Ovale Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foramen Ovale, Patent Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients who underwent PFO closure

Exclusion criteria

Unable to complete or adhere to the study

Treatment and study plan

PFO closure

Device

Surgery of PFO closure

Primary outcomes

ischemic stroke, Hemorrhagic stroke or transient ischemic attack

Time frame: 1 month, 6 months, 1 year, 3 years, 5 years

Secondary outcomes

atrial fibrillation

Time frame: 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
residual leaks

Time frame: 1 month, 6 months, 1 year, 3 years, 5 years
death

Time frame: 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
Other severe events related to PFO closure

Time frame: 1 month, 6 months, 1 year, 3 years, 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Chunlin Yin

CONTACT

[email protected]

13552566227

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2029
Study completion: 2029
First posted: May 14, 2024
Registry last updated: May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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