Russian Registry of Endovascular Closure of PFO

Recruiting now

Conditions studied: Patent Foramen Ovale

In brief

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.

Key facts

Study ID

NCT06156670

Run by

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

People needed

700

Starts

2023-12-01

Expected to finish

2025-12-31

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with an ischemic event (cryptogenic ischemic stroke, transient ischemic attack, embolism of other organs and systems) associated with a PFO;
• Presence of an open oval confirmed by ultrasound diagnostic methods;
• Age of patients from 18 years;
• Life expectancy of at least 1 year;
• Signed informed consent for endovascular closure of a PFO.

You may not qualify if…

• Inability to receive antiplatelet therapy;
• Presence of acute inflammatory diseases;
• Acute stage of cerebral circulatory failure (30 days);
• Myocardial infarction or aortocoronary bypass surgery within the previous 30 days;
• Carotid or vertebral artery dissection;
• Severe cardiac valve pathology;
• Presence of blood clots in the cardiac cavities;
• Refusal of the patient to participate in the study.

Where it is running

• National Medical Research Center for Cardiology, Ministry of Health of Russian Federation — Moscow, Russia (enrolling)

Full record on ClinicalTrials.gov

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