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NCT Number: NCT03298178

ASAN Medical Center Aortic Valve Replacement Registry

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Hospital

Seoul, South Korea

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Infective endocarditis

Treatment and study plan

TAVR

Procedure

All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea

Other names: transcatheter aortic valve replacement

SAVR

Procedure

All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea

Primary outcomes

  1. All cause death

    Time frame: 1 year

Secondary outcomes

  1. Cardiovascular mortality

    Time frame: 1,6 and 12 months and 5 years

  2. Cardiovascular mortality

    Time frame: 1,6 and 12 months and 5 years

    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

  3. Myocardial infarction

    Time frame: 1,6 and 12 months and 5 years

  4. Stroke

    Time frame: 1,6 and 12 months and 5 years

    all stroke and TIA

  5. Bleeding

    Time frame: 1,6 and 12 months and 5 years

  6. Operation site complication

    Time frame: 1,6 and 12 months and 5 years

  7. Vascular access site and access-related complication

    Time frame: 1,6 and 12 months and 5 years

  8. Acute kidney injury

    Time frame: at a later date between 30 days or discharge

  9. Event rate of permanent pacemaker insertion

    Time frame: 1,6 and 12 months and 5 years

  10. Other TAVR-related complication

    Time frame: 1,6 and 12 months and 5 years

    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)

  11. Prosthetic valve dysfunction

    Time frame: 1,6 and 12 months and 5 years

    Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation

  12. Event rate of composite endpoint

    Time frame: 1,6 and 12 months and 5 years

    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

  13. Structural valve deterioration

    Time frame: 1,6 and 12 months and 5 years

  14. Change of NYHA class

    Time frame: 30 days and 1 year

    the New York Heart Association (NYHA) Functional Classification

  15. Change of valve area

    Time frame: 30 days and 1 year

  16. Free from atrial fibrillation

    Time frame: 1,6 and 12 months and 5 years

Sponsors and collaborators

Lead sponsor

Ho-Jin Kim

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Acronym: ASAN-AVR

Important dates

Study start
2017
Primary completion
2023
Study completion
2027
First posted
Oct 2, 2017
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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