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.
Studieöversikt
Status
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Xinyi Xu
- Telefonnummer: +86 18930830756
- E-post: 3342@scmc.com.cn
Studera Kontakt Backup
- Namn: Kai Wang
- Telefonnummer: +86 15317921903
- E-post: 30192@scmc.com.cn
Studieorter
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Beijing, Kina
- Har inte rekryterat ännu
- Beijing Anzhen Hospital, Capital Medical University
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Kontakt:
- Yizhen Yang
- Telefonnummer: +86 13261985610
- E-post: yangyizhen2005@126.com
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Huvudutredare:
- Wenhui Wu
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Beijing, Kina
- Har inte rekryterat ännu
- FUWAI Hospital, CAMS&PUMC
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Kontakt:
- Jing Dong
- Telefonnummer: +86 15810174302
- E-post: Djing0324@163.com
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Huvudutredare:
- Guangzhi Zhao
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Shanghai, Kina
- Har inte rekryterat ännu
- East Hospital, Tongji University
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Kontakt:
- Ying Hao
- Telefonnummer: +86 18049898248
- E-post: supergreathy@163.com
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Huvudutredare:
- Linxiang Lu
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Gansu
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Lanzhou, Gansu, Kina
- Rekrytering
- The First Hospital of Lanzhou University
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Kontakt:
- Sixiong Hu
- Telefonnummer: +86 17693433056
- E-post: hsx1120587348@126.com
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Huvudutredare:
- Jizhe Xu
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Guangdong
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Guangzhou, Guangdong, Kina
- Har inte rekryterat ännu
- Guangdong Provincial People's Hospital
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Kontakt:
- Xiaotong Wen
- Telefonnummer: +86 18123548072
- E-post: 1127337995@qq.com
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Huvudutredare:
- Caojin Zhang
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Henan
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Zhengzhou, Henan, Kina
- Rekrytering
- Fuwai Central China Cardiovascular Hospital
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Kontakt:
- Menghao Li
- Telefonnummer: +86 18790660032
- E-post: edward564@163.com
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Huvudutredare:
- Shubo Song
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Hubei
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Wuhan, Hubei, Kina
- Rekrytering
- Zhongnan Hospital of Wuhan University
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Kontakt:
- Lei Wang
- Telefonnummer: +86 18702797617
- E-post: 119559295@qq.com
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Huvudutredare:
- Gangcheng Zhang
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Liaoning
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Shenyang, Liaoning, Kina
- Har inte rekryterat ännu
- General Hospital of Northern Theater Command, Chinese People's Liberation Army
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Huvudutredare:
- Qiguang Wang
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Kontakt:
- Jiawang Xiao
- Telefonnummer: +86 17790991821
- E-post: xjw492918837@126.com
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Shandong
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Jinan, Shandong, Kina
- Har inte rekryterat ännu
- Shandong Provincial Hospital
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Kontakt:
- mingliang Dong
- Telefonnummer: +86 13573157896
- E-post: dongmingliang2008@126.com
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Huvudutredare:
- Anbiao Wang
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Sichuan
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Chengdu, Sichuan, Kina
- Har inte rekryterat ännu
- Sichuan Provincial People's Hospital
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Kontakt:
- Xuechun Sun
- Telefonnummer: +86 18981838108
- E-post: sunxchun@163.com
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Huvudutredare:
- Yunshan Cao
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Yunnan
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Kunming, Yunnan, Kina
- Har inte rekryterat ännu
- Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
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Huvudutredare:
- Cheng Wang
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Kontakt:
- Kairui Yang
- Telefonnummer: +86 13987313055
- E-post: 416719379@qq.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
- 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.
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
|---|
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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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Incidence of Major Adverse Events
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Degree of device degradation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Lijun Fu, Shanghai Children's Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- SCMC2024ZD0527503
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
Start Date: 12 months after publication of the primary results End Date: No end date
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
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