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NCT06413147 Clinical Trial

Long-term Procedural and Device Related Complications of PFO Closure

Patent Foramen Ovale Clinical Trial

Official title:
Long-term Procedural and Device Related Complications of PFO Closure

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06413147
Other study ID # yinchunlin_PFO safety
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 30, 2024
Est. completion date May 30, 2029

Study information
Verified date May 2024
Source Xuanwu Hospital, Beijing
Contact Chunlin Yin
Phone 13552566227
Email yinclmail@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date May 30, 2029
Est. primary completion date May 30, 2029
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All patients who underwent PFO closure Exclusion Criteria: - Unable to complete or adhere to the study

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• PFO closure
Surgery of PFO closure

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Xuanwu Hospital, Beijing

Outcome
Type Measure Description Time frame Safety issue
Primary ischemic stroke, Hemorrhagic stroke or transient ischemic attack 1 month, 6 months, 1 year, 3 years, 5 years
Secondary atrial fibrillation 1 month, 6 months, 1 year, 3 years, 5 years
Secondary Hemorrhage related to the use of antithrombotic drugs 1 month, 6 months, 1 year, 3 years, 5 years
Secondary residual leaks 1 month, 6 months, 1 year, 3 years, 5 years
Secondary death 1 month, 6 months, 1 year, 3 years, 5 years
Secondary open-heart surgery 1 month, 6 months, 1 year, 3 years, 5 years
Secondary Other severe events related to PFO closure 1 month, 6 months, 1 year, 3 years, 5 years
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