Russian Registry of Endovascular Closure of PFO
Russian Registry of Endovascular Closure of Patent Foramen Ovale
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
700 participants
Dec 1, 2023
OBSERVATIONAL
Summary
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria8
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
The operation of endovascular closure of PFO is performed on X-ray angiographic devices with digital processing of X-ray images. Endovascular closure of a PFO will be performed by femoral venous access using the following instruments: diagnostic catheter, diagnostic guidewire, high-stiffness guidewire for delivery system, interatrial septum occluders of PFO, UNI, ASD types. Preoperative preparation and control of device implantation will be performed using modern echocardiographic equipment.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06156670