NCT06375070

Anticoagulants for PFO Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 277 (actual)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Patients who underwent both bubble transcranial Doppler (bubble-TCD) and transoesophageal echocardiography (TEE) at our institution were consecutively enrolled in this real-world case-control study from August 2016 through August 2023. The patients were categorized into three groups based on the degree of the shunt observed: mild (3-9 bubbles), moderate (10-30bubbles), and severe (more than 30 bubbles). In cases with mild-shunt (small-size) PFO, post-procedural anticoagulation or PFO closure was administered. Subsequent to the interventions, the follow-up encompassed the recording of migraine remission, recurrent neurological incidents, instances of major bleeding, and mortality.

Conditions

• Patent Foramen Ovale

Interventions

Type	Name	Description
PROCEDURE	PFO closure	PFO closure
DRUG	anticoagulant	rivaroxaban

Timeline

• Start date: 2016-08-01
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2024-04-19
• Last updated: 2024-04-19