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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 700 (estimated) |
| Sponsor | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation Government |
| Locations | 1 site (Moscow) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | January 29, 2025 |
| Trial ID | NCT06156670 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
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National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Moscow, Russia Recruiting
Study contacts
- Study coordinator: Andrey Tereschenko
- Email: andrew034@yandex.ru
- Phone: 84954150144
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Long-term outcomes after PFO closure at Severance Hospital
This registry tests how well percutaneous PFO closure works over the long term and what factors predict residual shunt, new atrial fibrillation, or other outcomes in adults who had the procedure.
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P3 Occluder System for closing a heart opening (PFO) after stroke
We are testing the P3 Occluder System to see if it safely and effectively closes a patent foramen ovale in adults who had a stroke related to their heart opening.
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PFO-Directed Therapy for Migraines: Closing the Hole or Using a Blood Thinner
This study tests whether closing a patent foramen ovale (PFO) plus 24 weeks of prasugrel works better for long-term migraine relief than prasugrel alone in people whose migraines improve on blood-thinning therapy.
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Comparing Cocoon vs Amplatzer PFO Occluders in Adults After Stroke or TIA
This trial tests whether the Cocoon PFO Occluder works as well as the Amplatzer PFO Occluder in adults who had a cryptogenic stroke or TIA and have a PFO requiring closure.
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Percutaneous repair of the atrial septum using the P3 Occluder System for PFO closure
This trial tests the P3 Occluder System to close a patent foramen ovale (PFO) in adults 18–65 who have had a stroke that may be linked to their PFO.
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Closing a PFO to improve glymphatic function and migraine symptoms
This study will see if closing a patent foramen ovale (PFO) improves glymphatic system function and reduces migraine attacks in adults with PFO and migraine.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.