Evaluation of Effectiveness and Safety of Aortic Valve Replacement in Routine Clinical Practice

Active, not recruiting

• Conditions: Aortic Valve Stenosis; Aortic Valve Disease
• Interventions: Procedure: Valve Replacement

• Registration Number: NCT03453567
• Lead Sponsor: Seung-Jung Park

Brief Summary

This study evaluated effectiveness and safety of aortic valve replacement in real-world clinical practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-02-27
• Study First Posted: 2018-03-05
• Study Start: 2018-05-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24
• Primary Completion: 2030-06-15
• Study Completion: 2030-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 900

Inclusion Criteria

• Age 19 and more
• Patient with aortic valve replacement

Exclusion Criteria

• Combined with mitral stenosis requiring surgery or aorta stenosis
• Acute bacterial endocarditis within 1 month of valve replacement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAVR	Valve Replacement	Transcatheter Aortic Valve Replacement
Sutureless AVR	Valve Replacement	Sutureless Aortic Valve Replacement
Conventional AVR	Valve Replacement	Conventional Aortic Valve Replacement

Primary Outcome Measures

Name	Time	Method
All-cause death	1 year

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality	5 years	A. Death due to proximate cardiac cause B. Death caused by noncoronary vascular condition C. All procedure-related/surgery-related death D. All valve-related death E. Sudden or unwitnessed death F. Death of unknown cause; Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years
NYHA class	30 days and 1 year	New York Heart Association (NYHA) Functional Classification
New onset atrial fibrillation	30 days and 1 year
Acute kidney injury	5 years	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years
TAVR-related complication	5 years	A. Conversion to open surgery B. Coronary obstruction C. Mitral valve apparatus damage or dysfunction D. Cardiac tamponade E. Endocarditis F. Valve thrombosis G. Valve malpositioning H. TAV-in-TAV deployment; Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years
Composite event	5 years	A. Device success B. Early safety (30 days); * Death, stroke, life-threatening bleeding, acute kidney injury, coronary stenosis requiring intervention, significant vascular complication, valve dysfunction requiring intervention C. Clinical efficacy (30 days); * Death, stroke, deteriorating heart failure or valve function requiring hospitalization, NYHA III or IV dyspnea, valve dysfunction; Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years
Structural valve deterioration	5 years	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years
The change of valve area	30 days and 1 year	Aortic valve area measured by echocardiography (mm2)
Myocardial infarction	5 years	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years
All stroke and transient ischemic attack	5 years	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years
Permanent pacemaker insertion	5 years	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years
Prosthetic valve dysfunction	5 years	A. Prosthetic aortic valve stenosis B. Prosthesis-patient mismatch C. Prosthetic aortic valve regurgitation; Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years
Bleeding	5 years	Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years
Access site complication	5 years	Operation site complication Vascular access site and access-related complication; Either Discharge or 30-day, at the earliest time point; 1-,6-, and 12-months, and 3-,5-years

Trial Locations

Locations (3)

Sejong Hospital; 🇰🇷 Bucheon, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Korea, Republic of