NCT06156670

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

2.1 years

First QC Date

November 27, 2023

Last Update Submit

January 27, 2025

Conditions

Patent Foramen Ovale

Keywords

Patent Foramen Ovalestroke

Outcome Measures

Primary Outcomes (2)

  • Efficacy and safety of endovascular closure of a PFO

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

    12 month

  • Baseline clinical and demographic characteristics

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

    12 month

Secondary Outcomes (1)

  • Procedural success rate of endovascular closure of PFO

    12 month

Interventions

PFO closureDEVICE

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.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study 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.

You may qualify if:

  • 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 may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Foramen Ovale, PatentStroke

Condition Hierarchy (Ancestors)

Heart Septal Defects, AtrialHeart Septal DefectsHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Central Study Contacts

Andrey Tereschenko

CONTACT

84954150144andrew034@yandex.ru

Vadim Yu Kuznetsov

CONTACT

vykuznetsov@cardio.ru

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2023

First Posted

December 5, 2023

Study Start

December 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)