Actively Recruiting
Russian Registry of Endovascular Closure of Patent Foramen Ovale
Led by National Medical Research Center for Cardiology, Ministry of Health of Russian Federation · Updated on 2025-01-29
700
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients over 18 years old in Russia who have undergone endovascular closure of patent foramen ovale (PFO), a heart condition linked to cryptogenic stroke and other thromboembolic events. This observational registry aims to describe patient characteristics, evaluate the safety and effectiveness of PFO closure, and understand long-term outcomes. The study is conducted across 29 medical centers experienced in performing these procedures. The treatment involves endovascular closure of the PFO using devices inserted via femoral venous access with X-ray guidance and echocardiographic monitoring. Various types of occluders are used, and the procedure is performed with specialized catheters and guidewires. No additional treatments are assigned by the registry, and data are collected as part of routine care. Participants provide baseline information during hospitalization and are followed up with a telephone interview 12 months after the procedure. Researchers collect data on procedural success, complications, stroke recurrence, neurological symptoms, and thromboembolic events. The study focuses on safety and efficacy outcomes over one year while ensuring patients receive standard care throughout.
CONDITIONS
Brief Title
Russian Registry of Endovascular Closure of PFO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Inability to receive antiplatelet therapy
- Presence of acute inflammatory diseases
- Acute stage of cerebral circulatory failure (within 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo the endovascular closure procedure of the patent foramen ovale (PFO) using specialized devices and imaging guidance.
1 in-person procedure visit
Duration - 12 months
Participants are followed up by telephone interview to assess safety, efficacy, and long-term outcomes one year after the procedure.
1 telephone follow-up
Trial Site Locations
Total: 1 location
1
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Moscow, Russia
Actively Recruiting
Research Team
A
Andrey Tereschenko
V
Vadim Yu Kuznetsov
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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