Transcatheter Mitral Valve Edge-to-Edge Repair SystemASSEE-SHDNCT07848152
Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention
An observational study of Transcatheter Mitral Valve Edge-to-Edge Repair System and Biodegradable Patent Foramen Ovale Closure Device, run by Shanghai Jiao Tong University School of Medicine at 11 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
- How many people
- 2,200 participants
- Where
- 11 sitesChina
- Study dates
- 30 Dec 2025to 31 Jan 2029
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Biodegradable PFO Closure Device Cohort: Patients with confirmed PFO-associated ischemic stroke who undergo implantation of a biodegradable PFO closure device. 2. 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.
Who may be able to join
- Patients undergoing implantation of a biodegradable PFO closure device.
- Patients undergoing transcatheter mitral valve edge-to-edge repair.
Who cannot join
- The participant expresses a desire to withdraw from the study.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Not yet recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing
Yizhen Yang, +86 13261985610, yangyizhen2005@126.com
Wenhui Wu
- Not yet recruiting
FUWAI Hospital, CAMS&PUMC
Beijing
Jing Dong, +86 15810174302, Djing0324@163.com
Guangzhi Zhao
- Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Xuechun Sun, +86 18981838108, sunxchun@163.com
Yunshan Cao
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Xiaotong Wen, +86 18123548072, 1127337995@qq.com
Caojin Zhang
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong
mingliang Dong, +86 13573157896, dongmingliang2008@126.com
Anbiao Wang
- Not yet recruiting
Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
Kunming, Yunnan
Kairui Yang, +86 13987313055, 416719379@qq.com
Cheng Wang
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Sixiong Hu, +86 17693433056, hsx1120587348@126.com
Jizhe Xu
- Not yet recruiting
East Hospital, Tongji University
Shanghai
Ying Hao, +86 18049898248, supergreathy@163.com
Linxiang Lu
- Not yet recruiting
General Hospital of Northern Theater Command, Chinese People's Liberation Army
Shenyang, Liaoning
Jiawang Xiao, +86 17790991821, xjw492918837@126.com
Qiguang Wang
- Recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
Lei Wang, +86 18702797617, 119559295@qq.com
Gangcheng Zhang
- Recruiting
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan
Menghao Li, +86 18790660032, edward564@163.com
Shubo Song
About this study
Official title: 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.
- Conditions
- Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
- Keywords
- Patent Foramen Ovale Closure Device, Transcatheter Mitral Valve Edge-to-Edge Repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Major Adverse Events
Incidence of major adverse events related to the biodegradable PFO closure or transcatheter mitral valve edge-to-edge repair procedure during follow-up.
Measured: 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
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.
Measured: 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
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.
Measured: At 1, 6, and 12 months after the procedure
Secondary outcomes (9)
Degree of device degradation
The degree of degradation of the biodegradable PFO closure device will be assessed by echocardiography during follow-up.
Measured: At 1, 6, and 12 months after the procedure
Incidence of residual shunt after PFO closure
The presence of residual shunt after implantation of the biodegradable PFO closure device will be assessed by echocardiography with contrast study, when applicable.
Measured: At 1, 6, and 12 months after the procedure.
Incidence of re-intervention after PFO closure
The percentage of participants requiring reapeat intervention or surgical treatment related to the PFO closure device during follow-up.
Measured: At 1, 6, and 12 months after the procedure.
Incidence of recurrent stroke after PFO closure
The occurrence of recurrent ischemic or hemorrhagic stroke during the follow-up period will be assessed by clinical evaluation and review of medical records.
Measured: At 1, 6, and 12 months after the procedure.
Incidence of device-related thrombosis after PFO closure
The occurrence of thrombosis related to the biodegradable PFO closure device during follow-up will be assessed by echocardiography and clinical assessment.
Measured: At 1, 6, and 12 months after the procedure.
Proportion of participants who underwent TEER and achieved immediate procedural success
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.
Measured: Within 24 hours after the procedure.
Incidence of subsequent open-heart surgery in the TEER group
The number of participants undergoing subsequent open-heart surgery related to TEER during follow-up.
Measured: At 1, 6, and 12 months after the procedure.
Incidence of ischemic or hemorrhagic stroke in the TEER group
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.
Measured: At 1, 6, and 12 months after the procedure.
Incidence of bleeding events in the TEER group
The occurrence of bleeding events during follow-up in the TEER group will be assessed by clinical evaluation and review of medical records.
Measured: At 1, 6, and 12 months after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start30 Dec 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Mitral Valve Edge-to-Edge Repair SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or 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
- Responsible party
- Principal investigator, Lijun Fu, Shanghai Jiao Tong University School of Medicine
- Investigators
- Lijun Fu, Principal investigator, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848152
- Sponsor's protocol ID
- SCMC2024ZD0527503
- Acronym
- ASSEE-SHD
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Active Surveillance and Safety and Efficacy Evaluation Indicators for Innovative Devices Used in Interventional Treatment of Structural Heart Disease
- ClinicalTrials.gov ID
- NCT07848152
- Acronym / sponsor ID
- ASSEE-SHD / SCMC2024ZD0527503
- Conditions
- Transcatheter Mitral Valve Edge-to-Edge Repair System, Biodegradable Patent Foramen Ovale Closure Device
- Keywords
- Patent Foramen Ovale Closure Device, Transcatheter Mitral Valve Edge-to-Edge Repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or 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
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Biodegradable PFO Closure Device Cohort: Patients with confirmed PFO-associated ischemic stroke who undergo implantation of a biodegradable PFO closure device. 2. 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.
Key inclusion criteria (2 listed)
- Patients undergoing implantation of a biodegradable PFO closure device.
- Patients undergoing transcatheter mitral valve edge-to-edge repair.
Key exclusion criteria (1 listed)
- The participant expresses a desire to withdraw from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Major Adverse Events
Time frame: 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
Time frame: 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
Time frame: 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.
9 secondary outcomes
Degree of device degradation
Time frame: At 1, 6, and 12 months after the procedure
Incidence of residual shunt after PFO closure
Time frame: At 1, 6, and 12 months after the procedure.
Incidence of re-intervention after PFO closure
Time frame: At 1, 6, and 12 months after the procedure.
Incidence of recurrent stroke after PFO closure
Time frame: At 1, 6, and 12 months after the procedure.
Incidence of device-related thrombosis after PFO closure
Time frame: At 1, 6, and 12 months after the procedure.
Proportion of participants who underwent TEER and achieved immediate procedural success
Time frame: Within 24 hours after the procedure.
Incidence of subsequent open-heart surgery in the TEER group
Time frame: At 1, 6, and 12 months after the procedure.
Incidence of ischemic or hemorrhagic stroke in the TEER group
Time frame: At 1, 6, and 12 months after the procedure.
Incidence of bleeding events in the TEER group
Time frame: At 1, 6, and 12 months after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lijun Fu principal investigator
Shanghai Children's Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Mitral Valve Edge-to-Edge Repair System and Biodegradable Patent Foramen Ovale Closure Device, run by Shanghai Jiao Tong University School of Medicine at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyi Xu (+86 18930830756, 3342@scmc.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Major Adverse Events (time frame: At 1, 6, and 12 months after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.