Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve

NCT ID: NCT06041308

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2025-12-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Bioprothetic valve

Groups undergoing cardiac valve surgery with bioprothetic valve.

valve

Intervention Type: OTHER

bioprothetic valve versus mechanical valve

Mechanical valve

Groups undergoing cardiac valve surgery with mechanical valves.

valve

Intervention Type: OTHER

bioprothetic valve versus mechanical valve

Interventions

valve

bioprothetic valve versus mechanical valve

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

-

• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nai-Hsin Chi

Role: STUDY_CHAIR

attending physician

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Nai-Hsin Chi

Role: CONTACT

chinaihsin@gmail.com

886-2-23123456 ext. 265081

Facility Contacts

Nai-Hsin Chi, M.D./Ph.D.

Role: primary

References

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.

Reference Type: DERIVED

PMID: 38995189 (View on PubMed)

Other Identifiers

202012072RIND

Identifier Type: -

Identifier Source: org_study_id