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.
Studienübersicht
Status
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Xinyi Xu
- Telefonnummer: +86 18930830756
- E-Mail: 3342@scmc.com.cn
Studieren Sie die Kontaktsicherung
- Name: Kai Wang
- Telefonnummer: +86 15317921903
- E-Mail: 30192@scmc.com.cn
Studienorte
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Beijing, China
- Noch keine Rekrutierung
- Beijing Anzhen Hospital, Capital Medical University
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Kontakt:
- Yizhen Yang
- Telefonnummer: +86 13261985610
- E-Mail: yangyizhen2005@126.com
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Hauptermittler:
- Wenhui Wu
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Beijing, China
- Noch keine Rekrutierung
- FUWAI Hospital, CAMS&PUMC
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Kontakt:
- Jing Dong
- Telefonnummer: +86 15810174302
- E-Mail: Djing0324@163.com
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Hauptermittler:
- Guangzhi Zhao
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Shanghai, China
- Noch keine Rekrutierung
- East Hospital, Tongji University
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Kontakt:
- Ying Hao
- Telefonnummer: +86 18049898248
- E-Mail: supergreathy@163.com
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Hauptermittler:
- Linxiang Lu
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Gansu
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Lanzhou, Gansu, China
- Rekrutierung
- The First Hospital of Lanzhou University
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Kontakt:
- Sixiong Hu
- Telefonnummer: +86 17693433056
- E-Mail: hsx1120587348@126.com
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Hauptermittler:
- Jizhe Xu
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Guangdong
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Guangzhou, Guangdong, China
- Noch keine Rekrutierung
- Guangdong Provincial People's Hospital
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Kontakt:
- Xiaotong Wen
- Telefonnummer: +86 18123548072
- E-Mail: 1127337995@qq.com
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Hauptermittler:
- Caojin Zhang
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Henan
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Zhengzhou, Henan, China
- Rekrutierung
- Fuwai Central China Cardiovascular Hospital
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Kontakt:
- Menghao Li
- Telefonnummer: +86 18790660032
- E-Mail: edward564@163.com
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Hauptermittler:
- Shubo Song
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Hubei
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Wuhan, Hubei, China
- Rekrutierung
- Zhongnan Hospital of Wuhan University
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Kontakt:
- Lei Wang
- Telefonnummer: +86 18702797617
- E-Mail: 119559295@qq.com
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Hauptermittler:
- Gangcheng Zhang
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Liaoning
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Shenyang, Liaoning, China
- Noch keine Rekrutierung
- General Hospital of Northern Theater Command, Chinese People's Liberation Army
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Hauptermittler:
- Qiguang Wang
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Kontakt:
- Jiawang Xiao
- Telefonnummer: +86 17790991821
- E-Mail: xjw492918837@126.com
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Shandong
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Jinan, Shandong, China
- Noch keine Rekrutierung
- Shandong Provincial Hospital
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Kontakt:
- mingliang Dong
- Telefonnummer: +86 13573157896
- E-Mail: dongmingliang2008@126.com
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Hauptermittler:
- Anbiao Wang
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Sichuan
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Chengdu, Sichuan, China
- Noch keine Rekrutierung
- Sichuan Provincial People's Hospital
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Kontakt:
- Xuechun Sun
- Telefonnummer: +86 18981838108
- E-Mail: sunxchun@163.com
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Hauptermittler:
- Yunshan Cao
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Yunnan
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Kunming, Yunnan, China
- Noch keine Rekrutierung
- Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
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Hauptermittler:
- Cheng Wang
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Kontakt:
- Kairui Yang
- Telefonnummer: +86 13987313055
- E-Mail: 416719379@qq.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
- 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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Major Adverse Events
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Degree of device degradation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Lijun Fu, Shanghai Children's Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- SCMC2024ZD0527503
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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-Sharing-Zeitrahmen
Start Date: 12 months after publication of the primary results End Date: No end date
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- CSR
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