NCT07709858

Brief Summary

This study is a multicenter, retrospective registry study using the CHATEAU Registry. The study will evaluate patients who underwent transcatheter aortic valve replacement between January 2021 and December 2025. The purpose of the study is to assess clinical outcomes and valve performance after TAVR in real-world practice, with a focus on procedural strategies, valve-related factors, and long-term outcomes. Patient clinical information, imaging findings, procedural data, echocardiographic results, and follow-up outcomes will be collected from existing medical records. No additional intervention, treatment, or study-specific visit will be performed.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress80%
Jan 2021Dec 2027

Study Start

First participant enrolled

January 1, 2021

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

7 years

First QC Date

July 12, 2026

Last Update Submit

July 12, 2026

Conditions

Keywords

CHATEAU RegistryTranscatheter Aortic Valve ReplacementTAVRAortic StenosisReal-world DataValve PerformanceClinical OutcomesMulticenter Registry

Outcome Measures

Primary Outcomes (1)

  • All-Cause Mortality

    Death from any cause occurring after transcatheter aortic valve replacement (TAVR) during follow-up.

    From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)

Secondary Outcomes (1)

  • Cardiovascular Mortality Stroke Heart Failure Hospitalization Myocardial Infarction Aortic Valve Reintervention Valve Hemodynamic Deterioration Prosthetic Valve Endocarditis/thrombosis Permanent pace maker insertion Major Bleeding

    From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)

Study Arms (1)

CHATEAU Registry Cohort

Consecutive adult patients with severe aortic valve disease who underwent transcatheter aortic valve replacement (TAVR) between January 1, 2021 and December 31, 2025 at participating centers in the CHATEAU Registry. Clinical, imaging, procedural, and follow-up data are collected retrospectively from routine clinical practice.

Procedure: Transcatheter Aortic Valve Replacement

Interventions

Transcatheter aortic valve replacement (TAVR) performed according to routine clinical practice using commercially available transcatheter heart valves and standard procedural techniques at participating centers.

CHATEAU Registry Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of consecutive adult patients who underwent clinically indicated transcatheter aortic valve replacement (TAVR) for severe native aortic valve disease at participating centers in the CHATEAU Registry. Clinical, imaging, procedural, echocardiographic, and follow-up data are retrospectively collected from routine clinical practice to evaluate long-term clinical outcomes and prosthetic valve performance in a real-world international cohort.

You may qualify if:

  • Adults (≥18 years of age).
  • Patients who underwent transcatheter aortic valve replacement (TAVR) for severe native aortic valve disease at participating centers.
  • TAVR performed between January 1, 2021 and December 31, 2025.
  • Availability of baseline procedural and follow-up clinical data in the institutional registry or medical records.

You may not qualify if:

  • Patients with insufficient clinical or procedural data for outcome assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, 03312, South Korea

RECRUITING

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

  • Osung Kwon, MD, PhD

    The Catholic University of Korea Eunpyeong St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Osung Kwon, MD. PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 17, 2026

Study Start

January 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations