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NCT Number: NCT06196684

Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Allografts Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiac Surgery

Chelyabinsk, Chelyabinsk Oblast, 454076, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Mitral allograft implantation

Procedure

Tricuspid valve replacement with mitral valve allograft

Primary outcomes

  1. Mortality (all cause and valve-related)

    Time frame: 30-day period

    Estimate rate of mortality (all cause and valve-related)

Secondary outcomes

  1. Neurologic events

    Time frame: 30-day period

    any neurological events in 30-day period

  2. Bleeding and transfusions

    Time frame: 30 days

    Freedom from major bleeding events

  3. Cardiac structural complications

    Time frame: 30 days

    any structural cardiac complication

  4. Acute kidney injury

    Time frame: 30 days

    freedom from type 3-4 AKI

  5. Allograft valve dysfunction

    Time frame: 30 days

    freedom from allograft valve stenosis or regurgitation

Sponsors and collaborators

Lead sponsor

Chelyabinsk Regional Clinical Hospital

Other Gov

Registry information

Official study title

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

Acronym: ESEMATS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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