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Russian Registry of Endovascular Closure of PFO

NCT06156670 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2025-01-29

No results posted yet for this study

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.

Conditions

  • Patent Foramen Ovale

Interventions

DEVICE

PFO closure

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.

Sponsors & Collaborators

  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06156670 on ClinicalTrials.gov