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NCT Number: NCT04442100

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

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

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tomsk National Research Medical Center of the Russian Academy of Sciences

Tomsk, Tomsk Oblast, 634012, Russia

Location status: Recruiting

Location contact

Boris N Kozlov, MD

PRINCIPAL_INVESTIGATOR

Elena B. Kim

CONTACT

[email protected]

Konstantin A Petlin, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

  • mitral valve disease requiring surgical disease

Exclusion criteria

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

Treatment and study plan

valve prosthetics

Procedure

prosthetics of heart valves with dentures "MedEng-Bio"

Primary outcomes

  1. death

    Time frame: 10 years after surgery

    death from any cause

  2. prosthetic complications

    Time frame: 10 years after surgery

    thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration

Study contacts

Contact information is provided by the study sponsor or research team.

Elena B. Kim

CONTACT

[email protected]

Konstantin A. Petlin, PhD

CONTACT

[email protected]

+79138259164

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2020
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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