Degenerative Mitral Valve Disease Clinical Trial
Official title:
Clinical and Fundamental Aspects of Prosthetics and Translocation of Mitral Valve Chordae
The study compares the efficacies of two surgical procedures for the treatment of mitral valve prolapse due to myxomatous degeneration of the mitral valve: the chordae replacement and the translocation of secondary mitral valve chordae.
Status | Active, not recruiting |
Enrollment | 64 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Isolated type II mitral valve insufficiency by A. Carpentier 2. Mitral regurgitation degree >2 3. Age >18 years 4. Signed informed consent to participate in the study Exclusion Criteria: 1. Any other cardiac surgeries 2. Age <18 years 3. Multiple organ failure 4. ReDo procedure 5. Persistent atrial fibrillation 6. Acute infective endocarditis 7. Refusal to sign informed consent |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Cardiology Research Institute, Tomsk NRMC | Tomsk |
Lead Sponsor | Collaborator |
---|---|
Tomsk National Research Medical Center of the Russian Academy of Sciences |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mitral regurgitation degree measure | Mitral regurgitation degree (from 1 to 4) assessed by echocardiography two weeks after surgery | Two weeks | |
Secondary | Surgical efficacy measure | Mitral regurgitation degree (from 1 to 4) assessed by echocardiography one year after surgery | One year | |
Secondary | ERO measure | Effective regurgitant orifice (ERO) (in square millimeters) assessed by echocardiography two weeks after surgery | Two weeks |
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