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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06196684
Other study ID # 26122023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 29, 2021
Est. completion date October 30, 2024

Study information

Verified date December 2023
Source Chelyabinsk Regional Clinical Hospital
Contact Mikhail Nuzhdin
Phone +79068608612
Email austesla2022@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to evaluate early safety and clinical efficacy of mitral allografts in tricuspid valve replacement for primary tricuspid valve diseases.


Description:

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with mid-term clinical efficacy ( mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication ) is going to be evaluated.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 30, 2024
Est. primary completion date September 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention. - Intraoperative findings suggested for tricuspid valve replacement rather than repair. Exclusion Criteria: - Pregnancy - Confirmed active drug addiction - Progressive HIV-infection - HIV-infected patients with CD4-cells count less than 250 - Patients with secondary tricuspid valve pathology (left-sided valve disease) - LV Ejection fraction less than 50%

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Mitral allograft implantation
Tricuspid valve replacement with mitral valve allograft

Locations

Country Name City State
Russian Federation Department of Cardiac Surgery Chelyabinsk

Sponsors (1)

Lead Sponsor Collaborator
Chelyabinsk Regional Clinical Hospital

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality (all cause and valve-related) Estimate rate of mortality (all cause and valve-related) 30-day period
Secondary Neurologic events any neurological events in 30-day period 30-day period
Secondary Bleeding and transfusions Freedom from major bleeding events 30 days
Secondary Cardiac structural complications any structural cardiac complication 30 days
Secondary Acute kidney injury freedom from type 3-4 AKI 30 days
Secondary Allograft valve dysfunction freedom from allograft valve stenosis or regurgitation 30 days
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