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NCT Number: NCT06591000

Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)

The aim of the study is to evaluate early safety, clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis in tricuspid valve replacement for primary tricuspid valve diseases.

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Key information

Conditions

Allograft Bioprosthesis Tricuspid Valve Disease

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiac Surgery

Chelyabinsk, Russia

Location status: Recruiting

Location contact

Yuri Malinovsky

CONTACT

About this study

Early safety (morbidity, mortality rate, freedom from any valve related complication) along with clinical efficacy ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are 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 40%

Treatment and study plan

tricuspid valve replacement

Procedure

Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis

Primary outcomes

  1. Mortality

    Time frame: 30-day period after surgery

    Freedom from all-cause mortality (%)

  2. Stroke

    Time frame: 30-day period after surgery

    Stroke rate (n,%)

  3. Severe valve dysfunction

    Time frame: 1-year after surgery, annually, assessed up to 3 years

    Number of patients free from peak valve gradient more than 6 mmHg and severe valve regurgitation (vena contracta no more than 6 mm), (n,%)

  4. Freedom from prosthetic endocarditis

    Time frame: 1-year after surgery, annually, assessed up to 3 years

    Number of patients free from prosthetic endocarditis (n,%)

  5. Freedom from reoperation

    Time frame: 1-year after surgery, annually, assessed up to 3 years

    Number of patients free from secondary operation due to severe valve (n,%) dysfunction (n,%)

  6. New pacemaker implantation

    Time frame: 1-year after surgery, annually, assessed up to 3 years

    Number of patients, free from pacemaker implantation after surgery (n,%)

Secondary outcomes

  1. Transvalvular gradient

    Time frame: 1 year after surgery, annually, assessed up to 3 years

    Peak and mean gradient (mmHg)

  2. Transprosthetic regurgitation

    Time frame: 1 year after surgery, annually, assessed up to 3 years

    Vena contracta (mm)

  3. Right atrial remodeling

    Time frame: 1 year after surgery, annually, assessed up to 3 years

    right atrium size (mm)

Study contacts

Contact information is provided by the study sponsor or research team.

Mikhail Nuzhdin, PhD

CONTACT

[email protected]

0079068608612

Yuri Malinovsky, PhD

CONTACT

[email protected]

0073517493732

Sponsors and collaborators

Lead sponsor

Chelyabinsk Regional Clinical Hospital

Other Gov

Registry information

Official study title

Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease

Important dates

Study start
2016
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

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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