AllograftNCT06591000
Clinical Efficacy and Long-term Outcomes of ALLOgraft Versus Stented Biological Prosthesis for Primary TRIcuspid Valve Disease (ALLOTRI)
An observational study of Allograft and Bioprosthesis, run by Chelyabinsk Regional Clinical Hospital at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Allograft, Bioprosthesis, Tricuspid Valve Disease
- What is being tested?
- tricuspid valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteRussia
- Study dates
- 14 Jan 2016to 14 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention
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 40%
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Department of Cardiac Surgery
Chelyabinsk
Yuri Malinovsky
About this study
Official title: Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease
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.
Read the detailed description
Early safety (morbidity, mortality rate, freedom from any valve related complication) along with clinical efficacy ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated.
- Conditions
- Allograft, Bioprosthesis, Tricuspid Valve Disease
- Being tested
- tricuspid valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tricuspid valve replacementProcedure or surgery
Complete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis
| Study group | Role | What they receive |
|---|---|---|
| Allograft tricuspid valve replacement | Patients underwent mitral allograft implantation for primary tricuspid valve disease Receives: Procedure: tricuspid valve replacement | |
| Stented biological tricuspid valve replacement | Patients underwent biological stented valve replacement for primary tricuspid valve disease Receives: Procedure: tricuspid valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Freedom from all-cause mortality (%)
Measured: 30-day period after surgery
Stroke
Stroke rate (n,%)
Measured: 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,%)
Measured: 1-year after surgery, annually, assessed up to 3 years
Freedom from prosthetic endocarditis
Number of patients free from prosthetic endocarditis (n,%)
Measured: 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,%)
Measured: 1-year after surgery, annually, assessed up to 3 years
New pacemaker implantation
Number of patients, free from pacemaker implantation after surgery (n,%)
Measured: 1-year after surgery, annually, assessed up to 3 years
Secondary outcomes (3)
Transvalvular gradient
Peak and mean gradient (mmHg)
Measured: 1 year after surgery, annually, assessed up to 3 years
Transprosthetic regurgitation
Vena contracta (mm)
Measured: 1 year after surgery, annually, assessed up to 3 years
Right atrial remodeling
right atrium size (mm)
Measured: 1 year after surgery, annually, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start14 Jan 2016
- Primary completion14 Dec 2024 (estimated)
- Study completion14 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AllograftStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 56 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
- Investigators
- Yuri Malinovsky, PhD, Study chair, Department of Cardiac Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591000
- Sponsor's protocol ID
- 14012016
- Status last verified
- Sep 2024
- First submitted
- 29 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40776959
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease
- ClinicalTrials.gov ID
- NCT06591000
- Acronym / sponsor ID
- 14012016
- Conditions
- Allograft, Bioprosthesis, Tricuspid Valve Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chelyabinsk Regional Clinical HospitalOther government
- Study start
- 14 Jan 2016 (actual)
- Primary completion
- 14 Dec 2024 (estimated)
- Study completion
- 14 Jun 2025 (estimated)
- First posted
- 19 Sep 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, clinical efficacy and long-term outcomes of mitral allografts and stented biological prosthesis in tricuspid valve replacement for primary tricuspid valve diseases.
Detailed description
Early safety (morbidity, mortality rate, freedom from any valve related complication) along with clinical efficacy ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), long term outcomes ( survival, freedom from reoperation, repeat endocarditis and other valve related complication ), echocardiografic assessment and MSCT scan for both groups of patients are going to be evaluated.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allograft tricuspid valve replacement | – | Procedure: tricuspid valve replacementPatients underwent mitral allograft implantation for primary tricuspid valve disease |
| Stented biological tricuspid valve replacement | – | Procedure: tricuspid valve replacementPatients underwent biological stented valve replacement for primary tricuspid valve disease |
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 and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention
Key inclusion criteria (2 listed)
- Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.
Key exclusion criteria (6 listed)
- Pregnancy
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 |
|---|---|---|
| tricuspid valve replacementComplete or partial tricuspid valve replacement with mitral allograft/ complete tricuspid valve replacement with biological prosthesis | Procedure or surgery | Allograft tricuspid valve replacement, Stented biological tricuspid valve replacement |
Primary outcome
Mortality
Time frame: 30-day period after surgery
Freedom from all-cause mortality (%)
Stroke
Time frame: 30-day period after surgery
Stroke rate (n,%)
Severe valve dysfunction
Time frame: 1-year after surgery, annually, assessed up to 3 years
Number of patients free from peak valve gradient more than 6 mmHg and severe valve regurgitation (vena contracta no more than 6 mm), (n,%)
Freedom from prosthetic endocarditis
Time frame: 1-year after surgery, annually, assessed up to 3 years
Number of patients free from prosthetic endocarditis (n,%)
Freedom from reoperation
Time frame: 1-year after surgery, annually, assessed up to 3 years
Number of patients free from secondary operation due to severe valve (n,%) dysfunction (n,%)
New pacemaker implantation
Time frame: 1-year after surgery, annually, assessed up to 3 years
Number of patients, free from pacemaker implantation after surgery (n,%)
3 secondary outcomes
Transvalvular gradient
Time frame: 1 year after surgery, annually, assessed up to 3 years
Transprosthetic regurgitation
Time frame: 1 year after surgery, annually, assessed up to 3 years
Right atrial remodeling
Time frame: 1 year after surgery, annually, assessed up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40776959Nuzhdin 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.
- Individual participant dataSharing planned: Undecided
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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.
Yuri Malinovsky, PhD study chair
Department of Cardiac Surgery
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 Allograft and Bioprosthesis, 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mikhail Nuzhdin, PhD (0079068608612, austesla2022@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30-day period after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06591000, which also lists 1 linked publication.
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 19 Sep 2024.