NCT03298178

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not 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 Progress89%
Dec 2017Jul 2027

First Submitted

Initial submission to the registry

September 21, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Expected
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

5.6 years

First QC Date

September 21, 2017

Last Update Submit

December 28, 2025

Conditions

Aortic Valve Stenosis

Keywords

TAVRTAVISAVR

Outcome Measures

Primary Outcomes (1)

  • All cause death

    1 year

Secondary Outcomes (16)

  • Cardiovascular mortality

    1,6 and 12 months and 5 years

  • Cardiovascular mortality

    1,6 and 12 months and 5 years

  • Myocardial infarction

    1,6 and 12 months and 5 years

  • Stroke

    1,6 and 12 months and 5 years

  • Bleeding

    1,6 and 12 months and 5 years

  • +11 more secondary outcomes

Study Arms (1)

all aortic stenosis

Procedure: TAVRProcedure: SAVR

Interventions

TAVRPROCEDURE

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

Also known as: transcatheter aortic valve replacement
all aortic stenosis
SAVRPROCEDURE

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

all aortic stenosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All successful transcatheter aortic valve replacement or surgical aortic valve replacement

You may qualify if:

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

You may not qualify if:

  • Infective endocarditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Hospital

Seoul, South Korea

Location

Related Publications (3)

  • 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.

    PMID: 36341221DERIVED

  • 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.

    PMID: 35112886DERIVED

  • 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.

    PMID: 34127247DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Seung-jung Park, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2017

First Posted

October 2, 2017

Study Start

December 1, 2017

Primary Completion

July 15, 2023

Study Completion (Estimated)

July 1, 2027

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

KR(1)