Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve

Valve Heart Disease Clinical Trial

Official title:

Long-term Outcomes of Bioprothetic Valve Versus Mechanical Valve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041308
• Other study ID #: 202012072RIND
• Status: Recruiting
• Start date: March 16, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2023
• Source: National Taiwan University Hospital
• Contact: Nai-Hsin Chi
• Phone: 886-2-23123456
• Email: chinaihsin[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This research aims to provide more recommendations and references for valve replacement in different patient populations.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 20 Years

Eligibility

Inclusion Criteria:This is a retrospective study, and we plan to utilize data from the hospital's integrated medical database and the National Health Insurance database from January 2007 to December 2019. We will identify all patients within the data who were diagnosed with valve diseases and underwent valve replacement surgery.

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Exclusion Criteria:Individuals under 20 years of age.

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Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valve Heart Disease

Intervention

Other:
• valve
bioprothetic valve versus mechanical valve

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1998-2019
Secondary	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	1998-2019