Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery

Tricuspid Valve Insufficiency Clinical Trial

— ESEMATS  

Official title:

Early Safety and Clinical Efficacy of Mitral Allografts in Patients With Primary Tricuspid Valve Disease Scheduled for Tricuspid Valve Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196684
• Other study ID #: 26122023
• Status: Recruiting
• 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
• 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%

Related Conditions & MeSH terms

• Allografts
• Tricuspid Valve Insufficiency

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