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Recruiting NCT06156670

Russian Registry of Endovascular Closure of PFO

Trial Parameters

Condition Patent Foramen Ovale
Sponsor National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Study Type OBSERVATIONAL
Phase N/A
Enrollment 700
Sex ALL
Min Age 18 Years
Max Age 70 Years
Start Date 2023-12-01
Completion 2025-12-31
Interventions
PFO closure

Brief Summary

The study will include all patients over 18 years of age who underwent endovascular closure of patent foramen ovale in medical centers in the Russian Federation, who gave written informed consent to the closure and provided personal data as part of inpatient medical care. The project participants will be 29 medical centers in the Russian Federation, where endovascular closure of patent foramen ovale is performed.

Eligibility Criteria

Inclusion Criteria: 1. Patients with an ischemic event (cryptogenic ischemic stroke, transient ischemic attack, embolism of other organs and systems) associated with a PFO; 2. Presence of an open oval confirmed by ultrasound diagnostic methods; 3. Age of patients from 18 years; 4. Life expectancy of at least 1 year; 5. Signed informed consent for endovascular closure of a PFO. Exclusion Criteria: 1. Inability to receive antiplatelet therapy; 2. Presence of acute inflammatory diseases; 3. Acute stage of cerebral circulatory failure (30 days); 4. Myocardial infarction or aortocoronary bypass surgery within the previous 30 days; 5. Carotid or vertebral artery dissection; 6. Severe cardiac valve pathology; 7. Presence of blood clots in the cardiac cavities; 8. Refusal of the patient to participate in the study.

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