Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention (ASSEE-SHD)
Establishment of Active Surveillance and Safety and Efficacy Evaluation Indicators for Innovative Devices Used in Interventional Treatment of Structural Heart Disease
This study aims to establish an active surveillance system to evaluate the safety and effectiveness of innovative medical devices used in the interventional treatment of structural heart disease. The devices of interest include a biodegradable patent foramen ovale (PFO) closure device and a transcatheter mitral valve edge-to-edge repair system. Clinical information from patients receiving these devices during routine clinical care will be collected and analyzed. The findings will help evaluate the safety and effectiveness of these devices and support the development of appropriate clinical evaluation indicators and long-term monitoring strategies.
연구 개요
상태
상태
정황
정황
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Xinyi Xu
- 전화번호: +86 18930830756
- 이메일: 3342@scmc.com.cn
연구 연락처 백업
- 이름: Kai Wang
- 전화번호: +86 15317921903
- 이메일: 30192@scmc.com.cn
연구 장소
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Beijing, 중국
- 아직 모집하지 않음
- Beijing Anzhen Hospital, Capital Medical University
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연락하다:
- Yizhen Yang
- 전화번호: +86 13261985610
- 이메일: yangyizhen2005@126.com
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수석 연구원:
- Wenhui Wu
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Beijing, 중국
- 아직 모집하지 않음
- FUWAI Hospital, CAMS&PUMC
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연락하다:
- Jing Dong
- 전화번호: +86 15810174302
- 이메일: Djing0324@163.com
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수석 연구원:
- Guangzhi Zhao
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Shanghai, 중국
- 아직 모집하지 않음
- East Hospital, Tongji University
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연락하다:
- Ying Hao
- 전화번호: +86 18049898248
- 이메일: supergreathy@163.com
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수석 연구원:
- Linxiang Lu
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Gansu
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Lanzhou, Gansu, 중국
- 모병
- The First Hospital of Lanzhou University
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연락하다:
- Sixiong Hu
- 전화번호: +86 17693433056
- 이메일: hsx1120587348@126.com
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수석 연구원:
- Jizhe Xu
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Guangdong
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Guangzhou, Guangdong, 중국
- 아직 모집하지 않음
- Guangdong Provincial People's Hospital
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연락하다:
- Xiaotong Wen
- 전화번호: +86 18123548072
- 이메일: 1127337995@qq.com
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수석 연구원:
- Caojin Zhang
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Henan
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Zhengzhou, Henan, 중국
- 모병
- Fuwai Central China Cardiovascular Hospital
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연락하다:
- Menghao Li
- 전화번호: +86 18790660032
- 이메일: edward564@163.com
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수석 연구원:
- Shubo Song
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Hubei
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Wuhan, Hubei, 중국
- 모병
- Zhongnan Hospital of Wuhan University
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연락하다:
- Lei Wang
- 전화번호: +86 18702797617
- 이메일: 119559295@qq.com
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수석 연구원:
- Gangcheng Zhang
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Liaoning
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Shenyang, Liaoning, 중국
- 아직 모집하지 않음
- General Hospital of Northern Theater Command, Chinese People's Liberation Army
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수석 연구원:
- Qiguang Wang
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연락하다:
- Jiawang Xiao
- 전화번호: +86 17790991821
- 이메일: xjw492918837@126.com
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Shandong
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Jinan, Shandong, 중국
- 아직 모집하지 않음
- Shandong Provincial Hospital
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연락하다:
- mingliang Dong
- 전화번호: +86 13573157896
- 이메일: dongmingliang2008@126.com
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수석 연구원:
- Anbiao Wang
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Sichuan
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Chengdu, Sichuan, 중국
- 아직 모집하지 않음
- Sichuan Provincial People's Hospital
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연락하다:
- Xuechun Sun
- 전화번호: +86 18981838108
- 이메일: sunxchun@163.com
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수석 연구원:
- Yunshan Cao
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Yunnan
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Kunming, Yunnan, 중국
- 아직 모집하지 않음
- Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
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수석 연구원:
- Cheng Wang
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연락하다:
- Kairui Yang
- 전화번호: +86 13987313055
- 이메일: 416719379@qq.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
- Biodegradable PFO Closure Device Cohort: Patients with confirmed PFO-associated ischemic stroke who undergo implantation of a biodegradable PFO closure device.
- Transcatheter Mitral Valve Edge-to-Edge Repair (TEER) Cohort: Patients with functional or degenerative mitral regurgitation who undergo transcatheter mitral valve edge-to-edge repair using a TEER system.
설명
Inclusion Criteria:
- Patients undergoing implantation of a biodegradable PFO closure device.
- Patients undergoing transcatheter mitral valve edge-to-edge repair.
Exclusion Criteria:
The participant expresses a desire to withdraw from the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
|---|
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Biodegradable Patent Foramen Ovale Closure Device
Participants with patent foramen ovale (PFO) who receive a biodegradable PFO closure device as part of routine clinical care will be included in this cohort. Clinical data will be collected to evaluate the safety and effectiveness of the device during follow-up. |
|
Transcatheter Mitral Valve Edge-to-Edge Repair System Cohort
Participants with degenerative or functional mitral regurgitation who undergo transcatheter mitral valve edge-to-edge repair using a transcatheter mitral valve edge-to-edge repair system. Safety and effectiveness outcomes will be assessed during follow-up. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Major Adverse Events
기간: At 1, 6, and 12 months after the procedure
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Incidence of major adverse events related to the biodegradable PFO closure or transcatheter mitral valve edge-to-edge repair procedure during follow-up. |
At 1, 6, and 12 months after the procedure
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Anatomical success of PFO closure within 12 months after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography
기간: At 1, 6, and 12 months after the procedure
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The proportion of participants achieving successful anatomical closure of the patent foramen ovale (PFO) during the 12-month follow-up period after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography. |
At 1, 6, and 12 months after the procedure
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Incidence of the composite clinical outcome of heart failure hospitalization, all-cause mortality, or cardiovascular mortality within 12 months after transcatheter edge-to-edge mitral valve repair
기간: At 1, 6, and 12 months after the procedure
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The proportion of participants experiencing at least one of the following events during the 12-month follow-up period after TEER: hospitalization for heart failure, all-cause death, or cardiovascular death. Events will be assessed through clinical follow-up and review of medical records. |
At 1, 6, and 12 months after the procedure
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Degree of device degradation
기간: At 1, 6, and 12 months after the procedure
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The degree of degradation of the biodegradable PFO closure device will be assessed by echocardiography during follow-up. |
At 1, 6, and 12 months after the procedure
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Incidence of residual shunt after PFO closure
기간: At 1, 6, and 12 months after the procedure.
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The presence of residual shunt after implantation of the biodegradable PFO closure device will be assessed by echocardiography with contrast study, when applicable. |
At 1, 6, and 12 months after the procedure.
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Incidence of re-intervention after PFO closure
기간: At 1, 6, and 12 months after the procedure.
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The percentage of participants requiring reapeat intervention or surgical treatment related to the PFO closure device during follow-up. |
At 1, 6, and 12 months after the procedure.
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Incidence of recurrent stroke after PFO closure
기간: At 1, 6, and 12 months after the procedure.
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The occurrence of recurrent ischemic or hemorrhagic stroke during the follow-up period will be assessed by clinical evaluation and review of medical records. |
At 1, 6, and 12 months after the procedure.
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Incidence of device-related thrombosis after PFO closure
기간: At 1, 6, and 12 months after the procedure.
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The occurrence of thrombosis related to the biodegradable PFO closure device during follow-up will be assessed by echocardiography and clinical assessment. |
At 1, 6, and 12 months after the procedure.
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Proportion of participants who underwent TEER and achieved immediate procedural success
기간: Within 24 hours after the procedure.
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Immediate procedural success is defined as successful completion of the transcatheter mitral valve edge-to-edge repair procedure with post-procedural mitral regurgitation (MR) grade ≤2+, as assessed by echocardiography. |
Within 24 hours after the procedure.
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Incidence of subsequent open-heart surgery in the TEER group
기간: At 1, 6, and 12 months after the procedure.
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The number of participants undergoing subsequent open-heart surgery related to TEER during follow-up. |
At 1, 6, and 12 months after the procedure.
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Incidence of ischemic or hemorrhagic stroke in the TEER group
기간: At 1, 6, and 12 months after the procedure.
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The occurrence of ischemic or hemorrhagic stroke during follow-up in the TEER group will be assessed by clinical evaluation and review of medical records. |
At 1, 6, and 12 months after the procedure.
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Incidence of bleeding events in the TEER group
기간: At 1, 6, and 12 months after the procedure.
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The occurrence of bleeding events during follow-up in the TEER group will be assessed by clinical evaluation and review of medical records. |
At 1, 6, and 12 months after the procedure.
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Lijun Fu, Shanghai Children's Medical Center
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- SCMC2024ZD0527503
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
De-identified individual participant-level data relevant to the study objectives, including baseline characteristics, procedural data, safety and efficacy outcomes, and follow-up data, will be shared.
IPD 공유 기간
Start Date: 12 months after publication of the primary results End Date: No end date
IPD 공유 액세스 기준
De-identified individual participant-level data and supporting information will be available to qualified researchers upon reasonable request and subject to review and approval by the study investigators. Access will be provided for scientifically justified research purposes in accordance with applicable regulations and data protection requirements. Requests should be submitted to the study investigators, and approved data will be shared through a secure data transfer mechanism.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .