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

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04442100
• Other study ID #: Easy Change
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2016
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2023
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: Ekaterina A/ Kosovskikh
• Phone: +79528912091
• Email: katekorovina93[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Procedure:
• valve prosthetics
prosthetics of heart valves with dentures "MedEng-Bio"

Locations

Country	Name	City	State
Russian Federation	Tomsk National Research Medical Center of the Russian Academy of Sciences	Tomsk	Tomsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	death from any cause	10 years after surgery
Primary	prosthetic complications	thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration	10 years after surgery