ASAN Medical Center Aortic Valve Replacement Registry

Aortic Valve Stenosis Clinical Trial

— ASAN-AVR  

Official title:

ASAN Medical Center Aortic Valve Replacement Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03298178
• Other study ID #: AMCCV 2017-09
• Status: Recruiting
• Start date: December 1, 2017
• Est. completion date: December 2031

Study information

• Verified date: June 2023
• Source: Asan Medical Center
• Contact: Do-yoon Kang, MD
• Phone: 82230101745
• Email: kdy1218[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.

Description:

All TAVR and SAVR cases will be enrolled retrospectively and prospectively.

This registry includes sub group analysis named STRATEGY AS(Role of Sarcopenia and frailTy in pRedicting outcomes After TranscathEter or surGical aortic valve replacement in elderlY patients with Aortic Stenosis: A prospective cohort study). For this sub group analysis, all enrolled subjects will have following tests : EQ-5D, KCCQ-12(Kansas City Cardiomyopathy Questionnaire), ADL(Activities of daily living), IADL(Instrumental. Activities of Daily Living), Nagi & Rosow-Breslau self-reported items, Previous fall events since 6 months (initial) or last visit(F/U), IPAQ(The International Physical Activity Questionnaires), Social frailty screening, CES-D(Center for Epidemiologic Studies Depression Scale), MNA-SF(Mini Nutritional Assessment - Short Form),SPPB score (Short Physical Performance Battery, usual gait speed, balance, chairstand), Multi-task gait test (counting7, animal, motor, motor&counting7), Grip strength, Bioimpedance analysis, Muscle tone at thigh and calf, UEF (Upper extremities function).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: December 2031
• Est. primary completion date: December 15, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All successful transcatheter aortic valve replacement or surgical aortic valve replacement

• Written consent

Exclusion Criteria

• Infective endocarditis

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Procedure:
• TAVR
All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea
• SAVR
All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Ho-Jin Kim	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause death		1 year
Secondary	Cardiovascular mortality		1,6 and 12 months and 5 years
Secondary	Cardiovascular mortality	Death due to proximate cardiac cause Death caused by noncoronary vascular condition All procedure-related/surgery-related death All valve-related death Sudden or unwitnessed death Death of unknown cause	1,6 and 12 months and 5 years
Secondary	Myocardial infarction		1,6 and 12 months and 5 years
Secondary	Stroke	all stroke and TIA	1,6 and 12 months and 5 years
Secondary	Bleeding		1,6 and 12 months and 5 years
Secondary	Operation site complication		1,6 and 12 months and 5 years
Secondary	Vascular access site and access-related complication		1,6 and 12 months and 5 years
Secondary	Acute kidney injury		at a later date between 30 days or discharge
Secondary	Event rate of permanent pacemaker insertion		1,6 and 12 months and 5 years
Secondary	Other TAVR-related complication	Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment(TAV : Transcatheter Aortic Valve)	1,6 and 12 months and 5 years
Secondary	Prosthetic valve dysfunction	Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation	1,6 and 12 months and 5 years
Secondary	Event rate of composite endpoint	Device success Early safety within 30 days Clinical efficacy after 30 days defined as death, stroke, valve dysfunction or heart failure requiring hospitalization, severe dyspnea or valve dysfunction NYHA class III or IV	1,6 and 12 months and 5 years
Secondary	Structural valve deterioration		1,6 and 12 months and 5 years
Secondary	Change of NYHA class	the New York Heart Association (NYHA) Functional Classification	30 days and 1 year
Secondary	Change of valve area		30 days and 1 year
Secondary	Free from atrial fibrillation		1,6 and 12 months and 5 years