NCT06591000

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2016

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

8.9 years

First QC Date

August 29, 2024

Last Update Submit

September 7, 2024

Conditions

AllograftBioprosthesisTricuspid Valve Disease

Outcome Measures

Primary Outcomes (6)

  • Mortality

    Freedom from all-cause mortality (%)

    30-day period after surgery

  • Stroke

    Stroke rate (n,%)

    30-day period after surgery

  • 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,%)

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

  • Freedom from prosthetic endocarditis

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

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

  • Freedom from reoperation

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

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

  • New pacemaker implantation

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

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

Secondary Outcomes (3)

  • Transvalvular gradient

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

  • Transprosthetic regurgitation

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

  • Right atrial remodeling

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

Study Arms (2)

Allograft tricuspid valve replacement

Patients underwent mitral allograft implantation for primary tricuspid valve disease

Procedure: tricuspid valve replacement

Stented biological tricuspid valve replacement

Patients underwent biological stented valve replacement for primary tricuspid valve disease

Procedure: tricuspid valve replacement

Interventions

tricuspid valve replacementPROCEDURE

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

Allograft tricuspid valve replacementStented biological tricuspid valve replacement

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiac Surgery

Chelyabinsk, Russia

RECRUITING

Related Publications (1)

  • Nuzhdin M, Malinovsky Y, Galchenko M, Komarov R, Fokin A, Nadtochiy N. Stented Biological Prosthesis Versus Mitral Allograft in Surgical Treatment of Tricuspid Valve Infective Endocarditis. Rev Cardiovasc Med. 2025 Jul 8;26(7):37204. doi: 10.31083/RCM37204. eCollection 2025 Jul.

    PMID: 40776959DERIVED

Study Officials

  • Yuri Malinovsky, PhD

    Department of Cardiac Surgery

    STUDY CHAIR

Central Study Contacts

Mikhail Nuzhdin, PhD

CONTACT

0079068608612austesla2022@gmail.com

Yuri Malinovsky, PhD

CONTACT

0073517493732mikhailnuzhdin@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 29, 2024

First Posted

September 19, 2024

Study Start

January 14, 2016

Primary Completion

December 14, 2024

Study Completion

June 14, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

RU(1)