Bioprosthesis FailureBIOCHOICENCT07210541
Comparative Analysis of Stented Biological Prosthesis Versus Aortic Allograft in Patients With Degenerative Aortic Valve Disease
An observational study of Bioprosthesis Failure and Allograft, run by Chelyabinsk Regional Clinical Hospital.
Trial summary
The aim of the observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either stented biological prosthesis or aortic allograft. Read more about this study
- Who is it for?
- Ages 60 to 74 years
- Conditions the study is for
- Bioprosthesis Failure, Allograft
- What is being tested?
- aortic valve/root replacement
- Type of treatment
- Surgery or procedure
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- 12 Jan 2017to 29 Sep 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 60 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with degenerative aortic valve disease, age 60-74 years
Who may be able to join
- Patients with degenerative aortic valve disease not emendable for aortic valve repair
- Elective surgery
Who cannot join
- Left ventricle ejection fraction less than 40%
- Redo surgery
- Indication for concomitant mitral valve replacement
- Aortic valve/root endocarditis
- Severe COPD
- Dialysis patients
About this study
Official title: Safety, Clinical Efficacy and Time-to-event Survival in Patients With Degenerative Aortic Valve Disease Scheduled for Stented Biological Aortic Valve Replacement Versus Allograft Aortic Root Replacement.
The aim of the observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either stented biological prosthesis or aortic allograft.
Read the detailed description
Early safety included morbidity, mortality rate, freedom from any valve related complications Clinical efficacy included mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication Time-to-event analysis included freedom from all-cause and cardio-vascular mortality, freedom from stroke, major bleeding, endocarditis, structural valve deterioration and reoperation
- Conditions
- Bioprosthesis Failure, Allograft
- Being tested
- aortic valve/root replacement
- Keywords
- aortic valve, bioprosthesis, allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aortic valve/root replacementProcedure or surgery
Aortic valve or aortic root replacement with stented biological prosthesis or aortic allograft
| Study group | Role | What they receive |
|---|---|---|
| Stented biological prosthesis | Patients who underwent aortic valve replacement with stented biological valve Receives: Procedure: aortic valve/root replacement | |
| Allograft aortic root replacement | Patients who underwent allograft aortic root replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Early cardio-vascular mortality
Measured: 30 days
Secondary outcomes (6)
Mortality
Cardio-vascular mortality
Measured: 2 years
Mortality
All-cause mortality
Measured: 2 years
Structural valve deterioration
New onset aortic regurgitation (vc >0,6) or escalated mean pressure gradient over 20 mmHg.
Measured: 2 years
Stroke
Ischemic stroke
Measured: 2 years
Reoperation
Reoperation for valve failure
Measured: 2 years
Endocarditis
Prosthetic valve endocarditis
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start12 Jan 2017
- Primary completion30 Jun 2024
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioprosthesis FailureStudies 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
- Retrospective
- Enrolment
- 93 participants (actual)
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
- NCT07210541
- Sponsor's protocol ID
- 30092025
- Acronym
- BIOCHOICE
- Status last verified
- Aug 2025
- First submitted
- 30 Sep 2025
- Last updated
- 7 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 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Clinical Efficacy and Time-to-event Survival in Patients With Degenerative Aortic Valve Disease Scheduled for Stented Biological Aortic Valve Replacement Versus Allograft Aortic Root Replacement.
- ClinicalTrials.gov ID
- NCT07210541
- Acronym / sponsor ID
- BIOCHOICE / 30092025
- Conditions
- Bioprosthesis Failure, Allograft
- Keywords
- aortic valve, bioprosthesis, allograft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Chelyabinsk Regional Clinical HospitalOther government
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 7 Oct 2025 (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 observational study is to compare safety, clinical efficacy and time-to-event survival in patients age of 60-74 years with degenerative aortic valve disease that underwent aortic valve replacement with either stented biological prosthesis or aortic allograft.
Detailed description
Early safety included morbidity, mortality rate, freedom from any valve related complications Clinical efficacy included mid-term survival, freedom from reoperation, repeat endocarditis and other valve related complication Time-to-event analysis included freedom from all-cause and cardio-vascular mortality, freedom from stroke, major bleeding, endocarditis, structural valve deterioration and reoperation
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stented biological prosthesis | – | Procedure: aortic valve/root replacementPatients who underwent aortic valve replacement with stented biological valve |
| Allograft aortic root replacement | – | –Patients who underwent allograft aortic root replacement |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with degenerative aortic valve disease, age 60-74 years
Key inclusion criteria (2 listed)
- Patients with degenerative aortic valve disease not emendable for aortic valve repair
- Elective surgery
Key exclusion criteria (6 listed)
- Left ventricle ejection fraction less than 40%
- Redo surgery
- Indication for concomitant mitral valve replacement
- Aortic valve/root endocarditis
- Severe COPD
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 |
|---|---|---|
| aortic valve/root replacementAortic valve or aortic root replacement with stented biological prosthesis or aortic allograft | Procedure or surgery | Stented biological prosthesis |
Primary outcome
Mortality
Time frame: 30 days
Early cardio-vascular mortality
6 secondary outcomes
Mortality
Time frame: 2 years
Mortality
Time frame: 2 years
Structural valve deterioration
Time frame: 2 years
Stroke
Time frame: 2 years
Reoperation
Time frame: 2 years
Endocarditis
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Bioprosthesis Failure
Not yet recruitingObservational study
REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Bioprosthesis Failure and Allograft, run by Chelyabinsk Regional Clinical Hospital.
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: finished, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 30 days). 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 7 Oct 2025.