CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement (CHATEAU)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement (TAVR)
• Intervention / Treatment: Procedure: Transcatheter Aortic Valve Replacement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Osung Kwon, MD. PhD; Phone Number: +821037085673; Email: oscaesar@gmail.com

Study Locations

• South Korea
  • Seoul, South Korea, 03312
    • Recruiting
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    • Contact: Osung Kwon, MD, PhD; Phone Number: +821037085673; Email: oscaesar@gmail.com
    • Contact: Email: oscaesar@gmail.com
    • Principal Investigator: Osung Kwon, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular Mortality Stroke Heart Failure Hospitalization Myocardial Infarction Aortic Valve Reintervention Valve Hemodynamic Deterioration Prosthetic Valve Endocarditis/thrombosis Permanent pace maker insertion Major Bleeding	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.	From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)

Collaborators and Investigators

• Sponsor: Eunpyeong St. Mary's Hospital
• Collaborators: Kokura Memorial Hospital; RCF@ICPS
• Investigators: Principal Investigator: Osung Kwon, MD, PhD, The Catholic University of Korea Eunpyeong St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 12, 2026
• First Submitted That Met QC Criteria: July 12, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 12, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Stenosis; Transcatheter Aortic Valve Replacement; TAVR; Clinical Outcomes; Real-world Data; Multicenter Registry; CHATEAU Registry; Valve Performance
• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Surgical Procedures, Operative; Cardiovascular Surgical Procedures; Cardiac Surgical Procedures; Thoracic Surgical Procedures; Prosthesis Implantation; Heart Valve Prosthesis Implantation; Transcatheter Aortic Valve Replacement
• Other Study ID Numbers: CHATEAU-REG-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No