Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery (ESEMATS)

December 26, 2023 updated by: Mikhail Nuzhdin, Chelyabinsk Regional Clinical Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with primary tricuspid valve disease

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with primary tricuspid valve insufficiency scheduled for tricuspid valve replacement
Procedure: Mitral allograft implantation
Tricuspid valve replacement with mitral valve allograft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality (all cause and valve-related)
Time Frame: 30-day period
Estimate rate of mortality (all cause and valve-related)
30-day period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurologic events
Time Frame: 30-day period
any neurological events in 30-day period
30-day period
Bleeding and transfusions
Time Frame: 30 days
Freedom from major bleeding events
30 days
Cardiac structural complications
Time Frame: 30 days
any structural cardiac complication
30 days
Acute kidney injury
Time Frame: 30 days
freedom from type 3-4 AKI
30 days
Allograft valve dysfunction
Time Frame: 30 days
freedom from allograft valve stenosis or regurgitation
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chelyabinsk Regional Clinical Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2021

Primary Completion (Estimated)

September 29, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

December 26, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26122023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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