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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Osung Kwon, MD. PhD
- 전화번호: +821037085673
- 이메일: oscaesar@gmail.com
연구 장소
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Seoul, 대한민국, 03312
- 모병
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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연락하다:
- Osung Kwon, MD, PhD
- 전화번호: +821037085673
- 이메일: oscaesar@gmail.com
-
연락하다:
- 이메일: oscaesar@gmail.com
-
수석 연구원:
- Osung Kwon, MD, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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Transcatheter aortic valve replacement (TAVR) performed according to routine clinical practice using commercially available transcatheter heart valves and standard procedural techniques at participating centers.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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All-Cause Mortality
기간: From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
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Death from any cause occurring after transcatheter aortic valve replacement (TAVR) during follow-up.
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From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cardiovascular Mortality Stroke Heart Failure Hospitalization Myocardial Infarction Aortic Valve Reintervention Valve Hemodynamic Deterioration Prosthetic Valve Endocarditis/thrombosis Permanent pace maker insertion Major Bleeding
기간: From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
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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.
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From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Osung Kwon, MD, PhD, The Catholic University of Korea Eunpyeong St. Mary's Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CHATEAU-REG-001
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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