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Aortic Valve StenosisASAN-AVRNCT03298178

ASAN Medical Center Aortic Valve Replacement Registry

An observational study of Aortic Valve Stenosis, run by Ho-Jin Kim at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Any age
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
TAVR and SAVR
Type of treatment
Surgery or procedure
How many people
900 participants
Where
1 siteSouth Korea
Study dates
1 Dec 2017to Jul 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All successful transcatheter aortic valve replacement or surgical aortic valve replacement

Who may be able to join

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

Who cannot join

  • Infective endocarditis

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Hospital

    Seoul

Other trials in South Korea

About this study

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

Read the detailed 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).

Being tested
TAVR, SAVR
Keywords
TAVR, TAVI, SAVR
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAVRProcedure or surgery

    Also called transcatheter aortic valve replacement

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

  • SAVRProcedure or surgery

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

Study groups in NCT03298178
Study groupRoleWhat they receive
all aortic stenosisNot described
Receives: Procedure: TAVR; Procedure: SAVR

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All cause death

    Measured: 1 year

Secondary outcomes (16)

  1. Cardiovascular mortality

    Measured: 1,6 and 12 months and 5 years

  2. 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

    Measured: 1,6 and 12 months and 5 years

  3. Myocardial infarction

    Measured: 1,6 and 12 months and 5 years

  4. Stroke

    all stroke and TIA

    Measured: 1,6 and 12 months and 5 years

  5. Bleeding

    Measured: 1,6 and 12 months and 5 years

  6. Operation site complication

    Measured: 1,6 and 12 months and 5 years

  7. Vascular access site and access-related complication

    Measured: 1,6 and 12 months and 5 years

  8. Acute kidney injury

    Measured: at a later date between 30 days or discharge

  9. Event rate of permanent pacemaker insertion

    Measured: 1,6 and 12 months and 5 years

  10. 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)

    Measured: 1,6 and 12 months and 5 years

  11. Prosthetic valve dysfunction

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

    Measured: 1,6 and 12 months and 5 years

  12. 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

    Measured: 1,6 and 12 months and 5 years

  13. Structural valve deterioration

    Measured: 1,6 and 12 months and 5 years

  14. Change of NYHA class

    the New York Heart Association (NYHA) Functional Classification

    Measured: 30 days and 1 year

  15. Change of valve area

    Measured: 30 days and 1 year

  16. Free from atrial fibrillation

    Measured: 1,6 and 12 months and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start1 Dec 2017
  3. Primary completion15 Jul 2023
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298178
Sponsor's protocol ID
AMCCV 2017-09
Acronym
ASAN-AVR
Status last verified
Dec 2025
First submitted
21 Sep 2017
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kim HJ, Kang DY, Park H, Ahn JM, Kim JB, Kim SO, Ok YJ, Lee SH, Pyo WK, Ko E, Lee SA, Kim DH, Park SJ, Park DW, Choo SJ. Comparison of Sutureless Bioprosthetic Valve With Surgical or TAVR for Severe Aortic Stenosis. JACC Asia. 2021 Oct 26;1(3):317-329. doi: 10.1016/j.jacasi.2021.08.007. eCollection 2021 Dec.

    PubMed 36341221

  • Yang Y, Ahn JM, Kang DY, Ko E, Kim S, Kim TO, Kim JH, Lee J, Lee SA, Kim DH, Kim HJ, Kim JB, Choo SJ, Park SJ, Park DW. Implication of Different ECG Left Ventricular Hypertrophy in Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2022 Feb 15;11(4):e023647. doi: 10.1161/JAHA.121.023647. Epub 2022 Feb 3.

    PubMed 35112886

  • Jeong YJ, Ahn JM, Kang DY, Park H, Ko E, Kim HJ, Kim JB, Choo SJ, Lee SA, Park SJ, Kim DH, Park DW. Incidence, Predictors, and Prognostic Impact of Immediate Improvement in Left Ventricular Systolic Function After Transcatheter Aortic Valve Implantation. Am J Cardiol. 2021 Aug 1;152:99-105. doi: 10.1016/j.amjcard.2021.04.037. Epub 2021 Jun 11.

    PubMed 34127247

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis, run by Ho-Jin Kim at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All cause death (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298178, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

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