Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07709858

CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Transcatheter Aortic Valve Replacement (TAVR) Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Seoul, 03312, South Korea

Location status: Recruiting

Location contact

Osung Kwon, MD, PhD

CONTACT

[email protected]

+821037085673

Osung Kwon, MD, PhD

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

The CHATEAU Registry is an international, multicenter, observational registry of patients undergoing transcatheter aortic valve replacement. This study will retrospectively analyze consecutive 4,000 patients treated with TAVR at participating centers from January 1, 2021 to December 31, 2025. Follow-up clinical outcomes will be assessed through December 31, 2027.

Eligible patients are adults who underwent TAVR for aortic valve disease. Data will be collected from existing medical records, including baseline demographics, comorbidities, laboratory findings, pre-procedural imaging data, procedural details, device information, post-procedural echocardiographic findings, discharge medications, and clinical follow-up outcomes.

The study aims to evaluate the association between patient-, anatomy-, device-, and procedure-related factors and subsequent clinical outcomes and valve performance. Outcomes of interest may include all-cause death, cardiovascular death, stroke, myocardial infarction, heart failure hospitalization, pacemaker implantation, valve hemodynamic deterioration, aortic valve reintervention, paravalvular regurgitation, and other TAVR-related clinical events.

Because this is a retrospective observational study, all treatment decisions were made according to routine clinical practice at each participating institution. The study does not involve randomization, assignment of treatment, additional procedures, or additional patient visits. All data will be handled in accordance with applicable institutional review board requirements and privacy regulations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Transcatheter aortic valve replacement

Procedure

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

Primary outcomes

  1. All-Cause Mortality

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

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

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

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

    Outcome events will be assessed during follow-up using routinely collected clinical and imaging data. Clinical events will be defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria, where applicable, and adjudicated according to each participating center's standard clinical practice.

Study contacts

Contact information is provided by the study sponsor or research team.

Osung Kwon, MD. PhD

CONTACT

[email protected]

+821037085673

Sponsors and collaborators

Lead sponsor

Eunpyeong St. Mary's Hospital

Other

Collaborators

  • Kokura Memorial Hospital
  • RCF@ICPS

Registry information

Official study title

Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: The Collaborative Hexagon-Asian Transcatheter Aortic Valve Replacement Union (CHATEAU) Registry

Acronym: CHATEAU

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 17, 2026
Registry last updated
Jul 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.