Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR)
Conditions
Keywords
CHATEAU Registry, Transcatheter Aortic Valve Replacement, TAVR, Aortic Stenosis, Real-world Data, Valve Performance, Clinical Outcomes, Multicenter Registry
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.
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.
Interventions
PROCEDURETranscatheter 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.
Sponsors
Eunpyeong St. Mary's Hospital
RCF@ICPS
Kokura Memorial Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-Cause Mortality | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
South Korea
Contacts
CONTACTOsung Kwon, MD. PhD
PRINCIPAL_INVESTIGATOROsung Kwon, MD, PhD
The Catholic University of Korea Eunpyeong St. Mary's Hospital
Outcome results
None listed