Russian Registry of Endovascular Closure of PFO

Launched by NATIONAL MEDICAL RESEARCH CENTER FOR CARDIOLOGY, MINISTRY OF HEALTH OF RUSSIAN FEDERATION · Nov 27, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Russian Registry of Endovascular Closure of PFO, is studying a procedure to close a small opening in the heart called a patent foramen ovale (PFO). This opening can sometimes lead to serious health issues, such as strokes. The trial is looking at patients over 18 years old who have experienced a stroke or other ischemic events linked to their PFO. To participate, individuals must have a confirmed open PFO and be able to give their consent to join the study.

Participants will be treated at one of 29 medical centers across Russia and will receive the endovascular closure procedure, which is done using a catheter—a thin tube inserted into a blood vessel. This procedure aims to reduce the risk of future strokes or other complications related to the PFO. Eligible patients should be generally healthy, but those with certain health issues, like recent heart attacks or severe heart valve problems, won't be able to join. If you're considering participating, you'll be helping researchers understand how this treatment can benefit others in the future.

Gender

ALL

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.