CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEunpyeong St. Mary's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with insufficient clinical or procedural data for outcome assessment.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Transcatheter Aortic Valve Replacement
Procedure/SurgeryTranscatheter aortic valve replacement (TAVR) performed according to routine clinical practice using commercially available transcatheter heart valves and standard procedural techniques at participating centers.
Treatment groups
4,000 Participants
are divided into 1 treatment groupGroup A: CHATEAU Registry Cohort1 intervention
Trial outcomes
Primary outcomes
1
All-Cause Mortality
Death from any cause occurring after transcatheter aortic valve replacement (TAVR) during follow-up.
Time frame
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
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.
Time frame
From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov