AllograftsESEMATSNCT06196684
Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery
An observational study of Allografts and Tricuspid Valve Insufficiency, run by Chelyabinsk Regional Clinical Hospital at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allografts, Tricuspid Valve Insufficiency
- What is being tested?
- Mitral allograft implantation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 29 Sep 2021to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary tricuspid valve disease
Who may be able to join
- 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.
Who cannot join
- 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%
Trial locations and contacts
1 site in 1 country.
Russia1 site
Department of Cardiac Surgery
Chelyabinsk, Chelyabinsk Oblast, 454076
About this study
Official title: 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.
Read the 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.
- Conditions
- Allografts, Tricuspid Valve Insufficiency
- Being tested
- Mitral allograft implantation
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral allograft implantationProcedure or surgery
Tricuspid valve replacement with mitral valve allograft
| Study group | Role | What they receive |
|---|---|---|
| Patients with primary tricuspid valve insufficiency scheduled for tricuspid valve replacement | Not described Receives: Procedure: Mitral allograft implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality (all cause and valve-related)
Estimate rate of mortality (all cause and valve-related)
Measured: 30-day period
Secondary outcomes (5)
Neurologic events
any neurological events in 30-day period
Measured: 30-day period
Bleeding and transfusions
Freedom from major bleeding events
Measured: 30 days
Cardiac structural complications
any structural cardiac complication
Measured: 30 days
Acute kidney injury
freedom from type 3-4 AKI
Measured: 30 days
Allograft valve dysfunction
freedom from allograft valve stenosis or regurgitation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start29 Sep 2021
- Primary completion29 Sep 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllograftsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chelyabinsk Regional Clinical Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mikhail Nuzhdin, Chelyabinsk Regional Clinical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196684
- Sponsor's protocol ID
- 26122023
- Acronym
- ESEMATS
- Status last verified
- Sep 2025
- First submitted
- 26 Dec 2023
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Safety and Clinical Efficacy of Mitral Allografts in Patients With Primary Tricuspid Valve Disease Scheduled for Tricuspid Valve Replacement
- ClinicalTrials.gov ID
- NCT06196684
- Acronym / sponsor ID
- ESEMATS / 26122023
- Conditions
- Allografts, Tricuspid Valve Insufficiency
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chelyabinsk Regional Clinical HospitalOther government
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with primary tricuspid valve insufficiency scheduled for tricuspid valve replacement | – | Procedure: Mitral allograft implantation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary tricuspid valve disease
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitral allograft implantationTricuspid valve replacement with mitral valve allograft | Procedure or surgery | Patients with primary tricuspid valve insufficiency scheduled for tricuspid valve replacement |
Primary outcome
Mortality (all cause and valve-related)
Time frame: 30-day period
Estimate rate of mortality (all cause and valve-related)
5 secondary outcomes
Neurologic events
Time frame: 30-day period
Bleeding and transfusions
Time frame: 30 days
Cardiac structural complications
Time frame: 30 days
Acute kidney injury
Time frame: 30 days
Allograft valve dysfunction
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allografts and Tricuspid Valve Insufficiency, run by Chelyabinsk Regional Clinical Hospital at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (all cause and valve-related) (time frame: 30-day period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.