Valve Heart DiseaseNCT06041308
Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve
An observational study of Valve Heart Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In this study, the investigators aim to use data identified through the hospital's integrated medical database and National Health Insurance database to explore the long-term performance and benefits of biological and mechanical valves. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Valve Heart Disease
- What is being tested?
- valve
- How many people
- 30,000 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2021to 1 Dec 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A total of 30,000 individuals (including this institution and other domestic units).
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Nai-Hsin Chi, M.D./Ph.D.
About this study
Official title: Long-term Outcomes of Bioprothetic Valve Versus Mechanical Valve
In this study, the investigators aim to use data identified through the hospital's integrated medical database and National Health Insurance database to explore the long-term performance and benefits of biological and mechanical valves. This research aims to provide more recommendations and references for valve replacement in different patient populations.
Read the detailed description
Long-term follow-up of valve surgery is essential in all cardiac surgeries and is the most commonly discussed indicator. The choice of valves has evolved over the past 30 years, offering two options: biological valves and mechanical valves. Biological valves have seen advancements in the last 15 years, including new processes and improved valve preservation methods. The question of whether these new process valves offer better long-term effectiveness has become a hot research topic in recent years.
Mechanical valves have a longer lifespan, but the need for long-term anticoagulant use to prevent mechanical valve thrombosis has raised concerns about anticoagulant side effects, abnormal clotting function, and bleeding. Biological valves, on the other hand, do not require long-term anticoagulation and only necessitate 2-3 months of anticoagulant treatment. However, the risk of biological valve degeneration results in an average lifespan of 10 to 20 years, which cannot match the durability of mechanical valves. This is the drawback of using biological valves.
Therefore, the investigators hope to utilize the hospital's integrated medical database and the long-term National Health Insurance database for tracking. The investigators aim to observe valve performance in different patient groups, such as young people, the elderly, patients on dialysis, those with rheumatic autoimmune diseases, and those taking specific medications, among others.
- Conditions
- Valve Heart Disease
- Being tested
- valve
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
valveOther
bioprothetic valve versus mechanical valve
| Study group | Role | What they receive |
|---|---|---|
| Bioprothetic valve | Groups undergoing cardiac valve surgery with bioprothetic valve. Receives: Other: valve | |
| Mechanical valve | Groups undergoing cardiac valve surgery with mechanical valves. Receives: Other: valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
included estimated survival using a Cox regression model. Survival data were obtained for all NHIRD databases. Operative mortality was defined as death during the index hospitalization or within 30 days of the operation. Long-term survival data included death from all causes.
survival outcome was measured months after the index operation.
Measured: 1998-2019
Secondary outcomes (1)
composite outcome and individual component of major adverse prosthesis-related events, including death, major bleeding, ischemic stroke, endocarditis, and aortic valve reoperation
each of which were defined as an emergency room visit or hospital admission with related diagnosis codes as the primary diagnosis
Measured: 1998-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start16 Mar 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 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 Valve Heart DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nai-Hsin Chi, Study chair, attending physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041308
- Sponsor's protocol ID
- 202012072RIND
- Status last verified
- Mar 2024
- First submitted
- 11 Sep 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Takei Y, Chou NK, Wei LY, Fu HY, Yu HY, Chi NH. Robotic transmitral approach in hypertrophic cardiomyopathy. Int J Surg. 2024 Nov 1;110(11):7391-7394. doi: 10.1097/JS9.0000000000001934. No abstract available.
PubMed 38995189
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcomes of Bioprothetic Valve Versus Mechanical Valve
- ClinicalTrials.gov ID
- NCT06041308
- Acronym / sponsor ID
- 202012072RIND
- Conditions
- Valve Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 Sep 2023 (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.
In this study, the investigators aim to use data identified through the hospital's integrated medical database and National Health Insurance database to explore the long-term performance and benefits of biological and mechanical valves. This research aims to provide more recommendations and references for valve replacement in different patient populations.
Detailed description
Long-term follow-up of valve surgery is essential in all cardiac surgeries and is the most commonly discussed indicator. The choice of valves has evolved over the past 30 years, offering two options: biological valves and mechanical valves. Biological valves have seen advancements in the last 15 years, including new processes and improved valve preservation methods. The question of whether these new process valves offer better long-term effectiveness has become a hot research topic in recent years.
Mechanical valves have a longer lifespan, but the need for long-term anticoagulant use to prevent mechanical valve thrombosis has raised concerns about anticoagulant side effects, abnormal clotting function, and bleeding. Biological valves, on the other hand, do not require long-term anticoagulation and only necessitate 2-3 months of anticoagulant treatment. However, the risk of biological valve degeneration results in an average lifespan of 10 to 20 years, which cannot match the durability of mechanical valves. This is the drawback of using biological valves.
Therefore, the investigators hope to utilize the hospital's integrated medical database and the long-term National Health Insurance database for tracking. The investigators aim to observe valve performance in different patient groups, such as young people, the elderly, patients on dialysis, those with rheumatic autoimmune diseases, and those taking specific medications, among others.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioprothetic valve | – | Other: valveGroups undergoing cardiac valve surgery with bioprothetic valve. |
| Mechanical valve | – | Other: valveGroups undergoing cardiac valve surgery with mechanical valves. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A total of 30,000 individuals (including this institution and other domestic units).
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| valvebioprothetic valve versus mechanical valve | Other | Bioprothetic valve, Mechanical valve |
Primary outcome
all-cause mortality
Time frame: 1998-2019
included estimated survival using a Cox regression model. Survival data were obtained for all NHIRD databases. Operative mortality was defined as death during the index hospitalization or within 30 days of the operation. Long-term survival data included death from all causes. survival outcome was measured months after the index operation.
1 secondary outcome
composite outcome and individual component of major adverse prosthesis-related events, including death, major bleeding, ischemic stroke, endocarditis, and aortic valve reoperation
Time frame: 1998-2019
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 38995189Takei Y, Chou NK, Wei LY, Fu HY, Yu HY, Chi NH. Robotic transmitral approach in hypertrophic cardiomyopathy. Int J Surg. 2024 Nov 1;110(11):7391-7394. doi: 10.1097/JS9.0000000000001934. No abstract available.
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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.
Nai-Hsin Chi study chair
attending physician
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 Valve Heart Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
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 0 inclusion and 1 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 18 Oct 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 Taiwan. 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 Nai-Hsin Chi (886-2-23123456 ext. 265081, chinaihsin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 1998-2019). 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 NCT06041308, 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 18 Oct 2024.