Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention

NCT07848152 — Recruiting, 2200 participants, Shanghai Jiao Tong University School of Medicine

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Establishment of Active Surveillance and Safety and Efficacy Evaluation Indicators for Innovative Devices Used in Interventional Treatment of Structural Heart Disease

Registry	NCT07848152, acronym ASSEE-SHD
Status	Recruiting
Study type	Observational
Enrollment	2200 (Estimated)
Sponsor	Shanghai Jiao Tong University School of Medicine (Other); collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital, Guangdong Provincial People's Hospital, LanZhou University, Shandong Provincial Hospital, Beijing Anzhen Hospital, Sichuan Provincial People's Hospital, Zhongnan Hospital, Shanghai East Hospital of Tongji University, ScienTech Medical, Valgen Medtech, The General Hospital of Northern Theater Command
Conditions	Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
Dates	start 2025-12-30, primary completion 2029-01-31 (estimated), completion 2029-01-31 (estimated), first posted 2026-09-29, last updated 2026-09-29
Locations	11 sites in China

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

+Outcome measures

Primary outcomes

Incidence of Major Adverse Events [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.
Anatomical success of PFO closure within 12 months after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography [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.
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 [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.

Secondary outcomes

Degree of device degradation [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.
Incidence of residual shunt after PFO closure [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.
Incidence of re-intervention after PFO closure [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.
Incidence of recurrent stroke after PFO closure [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.
Incidence of device-related thrombosis after PFO closure [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.
Proportion of participants who underwent TEER and achieved immediate procedural success [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.
Incidence of subsequent open-heart surgery in the TEER group [At 1, 6, and 12 months after the procedure.]: The number of participants undergoing subsequent open-heart surgery related to TEER during follow-up.
Incidence of ischemic or hemorrhagic stroke in the TEER group [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.
Incidence of bleeding events in the TEER group [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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Patients undergoing implantation of a biodegradable PFO closure device.
2. Patients undergoing transcatheter mitral valve edge-to-edge repair.

Exclusion Criteria:

The participant expresses a desire to withdraw from the study.

+Locations (11)

Facility	City	Country	Status
The First Hospital of Lanzhou University	Lanzhou, Gansu	China	Recruiting
Guangdong Provincial People's Hospital	Guangzhou, Guangdong	China	Not yet recruiting
Fuwai Central China Cardiovascular Hospital	Zhengzhou, Henan	China	Recruiting
Zhongnan Hospital of Wuhan University	Wuhan, Hubei	China	Recruiting
General Hospital of Northern Theater Command, Chinese People's Liberation Army	Shenyang, Liaoning	China	Not yet recruiting
Shandong Provincial Hospital	Jinan, Shandong	China	Not yet recruiting
Sichuan Provincial People's Hospital	Chengdu, Sichuan	China	Not yet recruiting
Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University	Kunming, Yunnan	China	Not yet recruiting
Beijing Anzhen Hospital, Capital Medical University	Beijing	China	Not yet recruiting
FUWAI Hospital, CAMS&PUMC	Beijing	China	Not yet recruiting
East Hospital, Tongji University	Shanghai	China	Not yet recruiting

+Investigators

Lijun Fu, Principal investigator, Shanghai Children's Medical Center

My Notes

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