NCT06041308

Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve

Long-term Outcomes of Bioprothetic Valve Versus Mechanical Valve

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30,000 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	valve	bioprothetic valve versus mechanical valve

Timeline

• Start date: 2021-03-16
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2023-09-18
• Last updated: 2024-10-18

Locations

1 site across 1 country: Taiwan