Russian Registry of Endovascular Closure of PFO

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorNational Medical Research Center for Cardiology, Ministry of Health of Russian Federation

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PFO closure

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Efficacy and safety of endovascular closure of a PFO

To evaluate the efficacy and safety of endovascular closure of a PFO in Russia,

Time frame
12 month
2

Baseline clinical and demographic characteristics

To describe the baseline clinical and demographic characteristics of patients with PFO who underwent its closure in Russia

Time frame
12 month

Secondary outcomes

1

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;

Time frame
12 month

Other outcomes

Sponsors and contacts

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