NCT06196684

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
6mo left

Started Sep 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Progress91%
Sep 2021Oct 2026

Study Start

First participant enrolled

September 29, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

December 26, 2023

Last Update Submit

September 30, 2025

Conditions

AllograftsTricuspid Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Mortality (all cause and valve-related)

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

    30-day period

Secondary Outcomes (5)

  • Neurologic events

    30-day period

  • Bleeding and transfusions

    30 days

  • Cardiac structural complications

    30 days

  • Acute kidney injury

    30 days

  • Allograft valve dysfunction

    30 days

Study Arms (1)

Patients with primary tricuspid valve insufficiency scheduled for tricuspid valve replacement

Procedure: Mitral allograft implantation

Interventions

Mitral allograft implantationPROCEDURE

Tricuspid valve replacement with mitral valve allograft

Patients with primary tricuspid valve insufficiency scheduled for 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

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 50%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiac Surgery

Chelyabinsk, Chelyabinsk Oblast, 454076, Russia

Location

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

September 29, 2021

Primary Completion (Estimated)

September 29, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)