Back to resultsThe Study of Biological Prosthetic Heart Valves With the "Easy Change" System
Primary Purpose
Heart Valve Diseases
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
valve prosthetics
Sponsored by
About this trial
This is an interventional treatment trial for Heart Valve Diseases
Eligibility Criteria
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.
Sites / Locations
- Tomsk National Research Medical Center of the Russian Academy of SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bioprosthesis
Arm Description
prosthetics of heart valves with dentures "MedEng-Bio"
Outcomes
Primary Outcome Measures
death
death from any cause
prosthetic complications
thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
Secondary Outcome Measures
Full Information
NCT ID
NCT04442100
First Posted
June 18, 2020
Last Updated
May 3, 2023
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04442100
Brief Title
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
Official Title
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bioprosthesis
Arm Type
Experimental
Arm Description
prosthetics of heart valves with dentures "MedEng-Bio"
Intervention Type
Procedure
Intervention Name(s)
valve prosthetics
Intervention Description
prosthetics of heart valves with dentures "MedEng-Bio"
Primary Outcome Measure Information:
Title
death
Description
death from any cause
Time Frame
10 years after surgery
Title
prosthetic complications
Description
thromboembolism, infectious endocarditis, hemorrhage, structural valve degeneration
Time Frame
10 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ekaterina A/ Kosovskikh
Phone
+79528912091
Email
katekorovina93@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Konstantin A. Petlin, PhD
Phone
+79138259164
Email
kpetlin@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris N. Kozlov, MD
Organizational Affiliation
Tomsk National Research Medical Center of the Russian Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tomsk National Research Medical Center of the Russian Academy of Sciences
City
Tomsk
State/Province
Tomsk Region
ZIP/Postal Code
634012
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekaterina A Kosovskikh
Phone
+79528912091
Email
katekorovina93@gmail.com
First Name & Middle Initial & Last Name & Degree
Boris N Kozlov, MD
First Name & Middle Initial & Last Name & Degree
Konstentin A Petlin, PhD
12. IPD Sharing Statement
Learn more about this trial
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
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