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Not yet recruiting NCT06413147

Long-term Procedural and Device Related Complications of PFO Closure

Observational Patent Foramen Ovale

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 →

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗