Not yet recruiting NCT06413147
Long-term Procedural and Device Related Complications of PFO Closure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PFO closure.
- Who it may be relevant to
- Registry conditions: Patent Foramen Ovale. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
We aimed to explore: (1)long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.
Interventions
- Device PFO closure
Surgery of PFO closure
Primary outcome measures
- ischemic stroke, Hemorrhagic stroke or transient ischemic attack [Time frame: 1 month, 6 months, 1 year, 3 years, 5 years]
Secondary outcome measures (6)
- 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]
Eligibility criteria
Inclusion criteria
- All patients who underwent PFO closure
Exclusion criteria
- Unable to complete or adhere to the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06413147 · yinchunlin_PFO safety