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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Xinyi Xu
- Telefonní číslo: +86 18930830756
- E-mail: 3342@scmc.com.cn
Studijní záloha kontaktů
- Jméno: Kai Wang
- Telefonní číslo: +86 15317921903
- E-mail: 30192@scmc.com.cn
Studijní místa
-
-
-
Beijing, Čína
- Zatím nenabíráme
- Beijing Anzhen Hospital, Capital Medical University
-
Kontakt:
- Yizhen Yang
- Telefonní číslo: +86 13261985610
- E-mail: yangyizhen2005@126.com
-
Vrchní vyšetřovatel:
- Wenhui Wu
-
Beijing, Čína
- Zatím nenabíráme
- FUWAI Hospital, CAMS&PUMC
-
Kontakt:
- Jing Dong
- Telefonní číslo: +86 15810174302
- E-mail: Djing0324@163.com
-
Vrchní vyšetřovatel:
- Guangzhi Zhao
-
Shanghai, Čína
- Zatím nenabíráme
- East Hospital, Tongji University
-
Kontakt:
- Ying Hao
- Telefonní číslo: +86 18049898248
- E-mail: supergreathy@163.com
-
Vrchní vyšetřovatel:
- Linxiang Lu
-
-
Gansu
-
Lanzhou, Gansu, Čína
- Nábor
- The First Hospital of Lanzhou University
-
Kontakt:
- Sixiong Hu
- Telefonní číslo: +86 17693433056
- E-mail: hsx1120587348@126.com
-
Vrchní vyšetřovatel:
- Jizhe Xu
-
-
Guangdong
-
Guangzhou, Guangdong, Čína
- Zatím nenabíráme
- Guangdong Provincial People's Hospital
-
Kontakt:
- Xiaotong Wen
- Telefonní číslo: +86 18123548072
- E-mail: 1127337995@qq.com
-
Vrchní vyšetřovatel:
- Caojin Zhang
-
-
Henan
-
Zhengzhou, Henan, Čína
- Nábor
- Fuwai Central China Cardiovascular Hospital
-
Kontakt:
- Menghao Li
- Telefonní číslo: +86 18790660032
- E-mail: edward564@163.com
-
Vrchní vyšetřovatel:
- Shubo Song
-
-
Hubei
-
Wuhan, Hubei, Čína
- Nábor
- Zhongnan Hospital of Wuhan University
-
Kontakt:
- Lei Wang
- Telefonní číslo: +86 18702797617
- E-mail: 119559295@qq.com
-
Vrchní vyšetřovatel:
- Gangcheng Zhang
-
-
Liaoning
-
Shenyang, Liaoning, Čína
- Zatím nenabíráme
- General Hospital of Northern Theater Command, Chinese People's Liberation Army
-
Vrchní vyšetřovatel:
- Qiguang Wang
-
Kontakt:
- Jiawang Xiao
- Telefonní číslo: +86 17790991821
- E-mail: xjw492918837@126.com
-
-
Shandong
-
Jinan, Shandong, Čína
- Zatím nenabíráme
- Shandong Provincial Hospital
-
Kontakt:
- mingliang Dong
- Telefonní číslo: +86 13573157896
- E-mail: dongmingliang2008@126.com
-
Vrchní vyšetřovatel:
- Anbiao Wang
-
-
Sichuan
-
Chengdu, Sichuan, Čína
- Zatím nenabíráme
- Sichuan Provincial People's Hospital
-
Kontakt:
- Xuechun Sun
- Telefonní číslo: +86 18981838108
- E-mail: sunxchun@163.com
-
Vrchní vyšetřovatel:
- Yunshan Cao
-
-
Yunnan
-
Kunming, Yunnan, Čína
- Zatím nenabíráme
- Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
-
Vrchní vyšetřovatel:
- Cheng Wang
-
Kontakt:
- Kairui Yang
- Telefonní číslo: +86 13987313055
- E-mail: 416719379@qq.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
- 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.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Incidence of Major Adverse Events
Časové okno: At 1, 6, and 12 months after the procedure
|
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
|
|
Anatomical success of PFO closure within 12 months after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography
Časové okno: At 1, 6, and 12 months after the procedure
|
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
|
|
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
Časové okno: At 1, 6, and 12 months after the procedure
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Degree of device degradation
Časové okno: At 1, 6, and 12 months after the procedure
|
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
|
|
Incidence of residual shunt after PFO closure
Časové okno: At 1, 6, and 12 months after the procedure.
|
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.
|
|
Incidence of re-intervention after PFO closure
Časové okno: At 1, 6, and 12 months after the procedure.
|
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.
|
|
Incidence of recurrent stroke after PFO closure
Časové okno: At 1, 6, and 12 months after the procedure.
|
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.
|
|
Incidence of device-related thrombosis after PFO closure
Časové okno: At 1, 6, and 12 months after the procedure.
|
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.
|
|
Proportion of participants who underwent TEER and achieved immediate procedural success
Časové okno: Within 24 hours after the procedure.
|
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.
|
|
Incidence of subsequent open-heart surgery in the TEER group
Časové okno: At 1, 6, and 12 months after the procedure.
|
The number of participants undergoing subsequent open-heart surgery related to TEER during follow-up. |
At 1, 6, and 12 months after the procedure.
|
|
Incidence of ischemic or hemorrhagic stroke in the TEER group
Časové okno: At 1, 6, and 12 months after the procedure.
|
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.
|
|
Incidence of bleeding events in the TEER group
Časové okno: At 1, 6, and 12 months after the procedure.
|
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.
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Lijun Fu, Shanghai Children's Medical Center
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- SCMC2024ZD0527503
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
Start Date: 12 months after publication of the primary results End Date: No end date
Kritéria přístupu pro sdílení IPD
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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .