Trials / Recruiting
RecruitingNCT04442100
The Study of Biological Prosthetic Heart Valves With the "Easy Change" System
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | valve prosthetics | prosthetics of heart valves with dentures "MedEng-Bio" |
Timeline
- Start date
- 2016-11-29
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2020-06-22
- Last updated
- 2023-05-06
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT04442100. Inclusion in this directory is not an endorsement.