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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorChelyabinsk Regional Clinical Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy

Confirmed active drug addiction

Progressive HIV-infection

HIV-infected patients with CD4-cells count less than 250

Trial population

Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • tricuspid valve replacement

    Procedure/Surgery

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

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Allograft tricuspid valve replacement1 intervention
Group B: Stented biological tricuspid valve replacement1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Freedom from all-cause mortality (%)

Time frame
30-day period after surgery
2

Stroke

Stroke rate (n,%)

Time frame
30-day period after surgery
3

Severe valve dysfunction

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

Time frame
1-year after surgery, annually, assessed up to 3 years
4

Freedom from prosthetic endocarditis

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

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

Secondary outcomes

1

Transvalvular gradient

Peak and mean gradient (mmHg)

Time frame
1 year after surgery, annually, assessed up to 3 years
2

Transprosthetic regurgitation

Vena contracta (mm)

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

Right atrial remodeling

right atrium size (mm)

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

Other outcomes

Sponsors and contacts

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