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

• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04442100
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 121
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Diseases	Procedure: valve prosthetics	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
• Actual Study Start Date: Nov 29, 2016
• Anticipated Primary Completion Date: Dec 31, 2026
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bioprosthesis prosthetics of heart valves with dentures "MedEng-Bio"	Procedure: valve prosthetics; prosthetics of heart valves with dentures "MedEng-Bio"

Outcome Measures

Primary Outcome Measures

1. death [10 years after surgery]

   death from any cause

2. prosthetic complications [10 years after surgery]

   thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tomsk National Research Medical Center of the Russian Academy of Sciences	Tomsk	Tomsk Region	Russian Federation	634012

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Boris N. Kozlov, MD, Tomsk National Research Medical Center of the Russian Academy of Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ekaterina Kosovskikh, Ekaterina Alekseevna Kosovskikh, Tomsk National Research Medical Center of the Russian Academy of Sciences
• ClinicalTrials.gov Identifier: NCT04442100
• Other Study ID Numbers: Easy Change
• First Posted: Jun 22, 2020
• Last Update Posted: Oct 6, 2021
• Last Verified: Oct 1, 2021

• Additional relevant MeSH terms: Heart Valve Diseases

Study Results

No Results Posted as of Oct 6, 2021