Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention (ASSEE-SHD)

September 26, 2026 updated by: Lijun Fu, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Beijing Anzhen Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Wenhui Wu
      • Beijing, China
        • Not yet recruiting
        • FUWAI Hospital, CAMS&PUMC
        • Contact:
        • Principal Investigator:
          • Guangzhi Zhao
      • Shanghai, China
        • Not yet recruiting
        • East Hospital, Tongji University
        • Contact:
        • Principal Investigator:
          • Linxiang Lu
    • Gansu
      • Lanzhou, Gansu, China
        • Recruiting
        • The First Hospital of Lanzhou University
        • Contact:
        • Principal Investigator:
          • Jizhe Xu
    • Guangdong
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Caojin Zhang
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Fuwai Central China Cardiovascular Hospital
        • Contact:
        • Principal Investigator:
          • Shubo Song
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Zhongnan Hospital of Wuhan University
        • Contact:
        • Principal Investigator:
          • Gangcheng Zhang
    • Liaoning
      • Shenyang, Liaoning, China
        • Not yet recruiting
        • General Hospital of Northern Theater Command, Chinese People's Liberation Army
        • Principal Investigator:
          • Qiguang Wang
        • Contact:
    • Shandong
      • Jinan, Shandong, China
        • Not yet recruiting
        • Shandong Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Anbiao Wang
    • Sichuan
      • Chengdu, Sichuan, China
        • Not yet recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • Yunshan Cao
    • Yunnan
      • Kunming, Yunnan, China
        • Not yet recruiting
        • Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
        • Principal Investigator:
          • Cheng Wang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
At 1, 6, and 12 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of device degradation
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

LanZhou University
Shandong Provincial Hospital
Guangdong Provincial People's Hospital
Beijing Anzhen Hospital
Zhongnan Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Sichuan Provincial People's Hospital
The General Hospital of Northern Theater Command
Shanghai East Hospital of Tongji University
ScienTech Medical
Valgen Medtech

Investigators

  • Principal Investigator: Lijun Fu, Shanghai Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2025

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

September 22, 2026

First Submitted That Met QC Criteria

September 26, 2026

First Posted (Actual)

September 29, 2026

Study Record Updates

Last Update Posted (Actual)

September 29, 2026

Last Update Submitted That Met QC Criteria

September 26, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SCMC2024ZD0527503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Time Frame

Start Date: 12 months after publication of the primary results End Date: No end date

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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