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The Study of Biological Prosthetic Heart Valves With the "Easy Change" System | Clinical Trials | Clareo Health

RECRUITINGNA

The Study of Biological Prosthetic Heart Valves With the "Easy Change" System

NCT04442100•Tomsk National Research Medical Center of the Russian Academy of Sciences

Summary

Detailed Description

The study of new biological heart valves with the "easy change" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality. Antithrombotic therapy after new biological valve prosthesis is studied. Transesophageal ultrasound is used for assessment of aortic strain, left ventricular strain, and 3D reconstruction of implanted bioprosthesis. The quality of life of patients is assessed using SF36 questionnaire. Heart failure after surgery is assessed by six-minute walking test and plasma BNP level.

Eligibility

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 / m2, average gradient more than 40 mm RT. Art;
•o patients who require coronary artery bypass grafting with moderate aortic stenosis - indexed area of the hole 0.5 - 1 cm2 / m2, the average gradient is more than 20 mm RT. Art., Regardless of symptoms;patients with symptoms of aortic stenosis, regardless of the severity of stenosis)
•2. mitral valve disease requiring surgical disease

Exclusion Criteria

•1. the need for prosthetics of two or more valves
•2. patients with a decrease in LVEF of less than 45%;
•3. the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death
•4. high pulmonary hypertension (SDJ above 60 mm Hg. Art.);
•5. the diameter of the ascending aorta is more than 45 mm;
•6. unwillingness of the patient to participate in the study.

Locations (1)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomsk Oblast, Russia

Key Dates

Start Date

November 29, 2016

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

May 6, 2023

Enrollment

500

ESTIMATED participants

Conditions

Heart Valve Diseases

Interventions

valve prosthetics

PROCEDURE

Contacts

Ekaterina A/ Kosovskikh

CONTACT

+79528912091 katekorovina93@gmail.com

Konstantin A. Petlin, PhD

CONTACT

+79138259164 kpetlin@yandex.ru

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Study of Biological Prosthetic Heart Valves With the "Easy Change" System

Inclusion Criteria

Exclusion Criteria

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