About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
The study will include all patients over 18 years of age who underwent endovascular closure of a 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 a patent foramen ovale is performed.
Trial design
Cohort
Prospective
Treatments tested in this trial
PFO closure
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Efficacy and safety of endovascular closure of a PFO
To evaluate the efficacy and safety of endovascular closure of a PFO in Russia,
Baseline clinical and demographic characteristics
To describe the baseline clinical and demographic characteristics of patients with PFO who underwent its closure in Russia
Secondary outcomes
Procedural success rate of endovascular closure of PFO
To evaluate the procedural success rate of endovascular closure of PFO and the incidence of adverse events;
Sponsors and contacts
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