Clinical trial Recruiting at 1 site Observational Ages 18 to 70

Registry of Endovascular Closure of Patent Foramen Ovale in Russia

Official title: Russian Registry of Endovascular Closure of Patent Foramen Ovale

Run by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · NCT06156670 · Data updated 2026-11-12

This study is looking at how closing a small hole in the heart called a patent foramen ovale (PFO) affects people over 18 who have had unexplained strokes, to see if it can help improve their health.

More Patent Foramen Ovale trials

Quick facts

Study typeObservational
Ages18 Years to 70 Years
SexAll
Enrollment700 (estimated)
SponsorNational Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Government
Locations1 site (Moscow)
StatusRecruiting
StartedDecember 1, 2023
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedJanuary 29, 2025
Trial IDNCT06156670 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 who have experienced ischemic events linked to a PFO and can provide informed consent.

Probably not a fit

Patients who cannot receive antiplatelet therapy or have acute inflammatory diseases will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study involves patients over 18 years old who have undergone endovascular closure of a patent foramen ovale (PFO) across 29 medical centers in the Russian Federation. It aims to gather data on the relationship between PFO and cryptogenic strokes, which are strokes of undetermined origin. Participants will provide informed consent and personal data as part of their inpatient medical care. The study seeks to enhance understanding of PFO's role in ischemic events and improve patient outcomes.

Why it matters

Potential benefit: If successful, this study could lead to better management and treatment strategies for patients with cryptogenic strokes associated with PFO.

How similar studies have gone: Other studies have indicated a significant association between PFO and cryptogenic strokes, suggesting that this approach is supported by existing literature.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
    Moscow, Russia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.