NCT06041308

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 18, 2024

Status Verified

March 1, 2024

Enrollment Period

3.7 years

First QC Date

September 11, 2023

Last Update Submit

October 16, 2024

Conditions

Valve Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • composite outcome and individual component of major adverse prosthesis-related events, including death, major bleeding, ischemic stroke, endocarditis, and aortic valve reoperation

    1998-2019

Study Arms (2)

Bioprothetic valve

Groups undergoing cardiac valve surgery with bioprothetic valve.

Other: valve

Mechanical valve

Groups undergoing cardiac valve surgery with mechanical valves.

Other: valve

Interventions

valveOTHER

bioprothetic valve versus mechanical valve

Bioprothetic valveMechanical valve

Eligibility Criteria

AgeUp to 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A total of 30,000 individuals (including this institution and other domestic units).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38995189DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Nai-Hsin Chi

    attending physician

    STUDY CHAIR

Central Study Contacts

Nai-Hsin Chi

CONTACT

886-2-23123456chinaihsin@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

March 16, 2021

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

October 18, 2024

Record last verified: 2024-03

Locations

TW(1)