Aortic Valve StenosisCHATEAUNCT07709858
CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement
An observational study of Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement (TAVR), run by Eunpyeong St. Mary's Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement (TAVR)
- What is being tested?
- Transcatheter Aortic Valve Replacement
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients with insufficient clinical or procedural data for outcome assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312
Osung Kwon, MD, PhD, +821037085673, oscaesar@gmail.com
oscaesar@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Transcatheter Aortic Valve Replacement
- Keywords
- CHATEAU Registry, Transcatheter Aortic Valve Replacement, TAVR, Aortic Stenosis, Real-world Data, Valve Performance, Clinical Outcomes, Multicenter Registry
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve ReplacementProcedure or surgery
Transcatheter aortic valve replacement (TAVR) performed according to routine clinical practice using commercially available transcatheter heart valves and standard procedural techniques at participating centers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Transcatheter Aortic Valve Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
Death from any cause occurring after transcatheter aortic valve replacement (TAVR) during follow-up.
Measured: 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.
Measured: From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Jan 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunpyeong St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- RCF@ICPS, Kokura Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Osung Kwon, MD, PhD, Principal investigator, The Catholic University of Korea Eunpyeong St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709858
- Sponsor's protocol ID
- CHATEAU-REG-001
- Acronym
- CHATEAU
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: The Collaborative Hexagon-Asian Transcatheter Aortic Valve Replacement Union (CHATEAU) Registry
- ClinicalTrials.gov ID
- NCT07709858
- Acronym / sponsor ID
- CHATEAU / CHATEAU-REG-001
- Keywords
- CHATEAU Registry, Transcatheter Aortic Valve Replacement, TAVR, Aortic Stenosis, Real-world Data, Valve Performance, Clinical Outcomes, Multicenter Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Eunpyeong St. Mary's HospitalUniversity, hospital or other
- Collaborators
- RCF@ICPS, Kokura Memorial Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHATEAU Registry Cohort | – | Procedure: Transcatheter Aortic Valve ReplacementConsecutive 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with insufficient clinical or procedural data for outcome assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter Aortic Valve ReplacementTranscatheter aortic valve replacement (TAVR) performed according to routine clinical practice using commercially available transcatheter heart valves and standard procedural techniques at participating centers. | Procedure or surgery | CHATEAU Registry Cohort |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Osung Kwon, MD, PhD principal investigator
The Catholic University of Korea Eunpyeong St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Transcatheter Aortic Valve Replacement (TAVR), run by Eunpyeong St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osung Kwon, MD. PhD (+821037085673, oscaesar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality (time frame: From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.