NCT03453567

Brief Summary

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

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
54mo left

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

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 Progress64%
May 2018Dec 2030

First Submitted

Initial submission to the registry

February 27, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

May 10, 2018

Completed
12.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2030

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

12.1 years

First QC Date

February 27, 2018

Last Update Submit

December 28, 2025

Conditions

Aortic Valve DiseaseAortic Valve Stenosis

Keywords

TAVRSAVRTAVIConventional AVRSutureless AVR

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    1 year

Secondary Outcomes (14)

  • Cardiovascular mortality

    5 years

  • Myocardial infarction

    5 years

  • All stroke and transient ischemic attack

    5 years

  • Bleeding

    5 years

  • Access site complication

    5 years

  • +9 more secondary outcomes

Study Arms (3)

TAVR

Transcatheter Aortic Valve Replacement

Procedure: Valve Replacement

Sutureless AVR

Sutureless Aortic Valve Replacement

Procedure: Valve Replacement

Conventional AVR

Conventional Aortic Valve Replacement

Procedure: Valve Replacement

Interventions

Valve ReplacementPROCEDURE

Aortic valve replacement

Conventional AVRSutureless AVRTAVR

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with aortic valve replacement

You may qualify if:

  • Age 19 and more
  • Patient with aortic valve replacement

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sejong Hospital

Bucheon-si, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, South Korea

Location

MeSH Terms

Conditions

Aortic Valve DiseaseAortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Suk-Jung Choo, 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, Division of Cardiology

Study Record Dates

First Submitted

February 27, 2018

First Posted

March 5, 2018

Study Start

May 10, 2018

Primary Completion (Estimated)

June 15, 2030

Study Completion (Estimated)

December 15, 2030

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

KR(3)