NCT07848152

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,200

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Dec 2025

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress25%
Dec 2025Jan 2029

Study Start

First participant enrolled

December 30, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

3.1 years

First QC Date

September 22, 2026

Last Update Submit

September 26, 2026

Conditions

Transcatheter Mitral Valve Edge-to-Edge Repair SystemBiodegradable Patent Foramen Ovale Closure Device

Keywords

Patent Foramen Ovale Closure DeviceTranscatheter Mitral Valve Edge-to-Edge Repair

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    At 1, 6, and 12 months after the procedure

Secondary Outcomes (9)

  • Degree of device degradation

    At 1, 6, and 12 months after the procedure

  • Incidence of residual shunt after PFO closure

    At 1, 6, and 12 months after the procedure.

  • Incidence of re-intervention after PFO closure

    At 1, 6, and 12 months after the procedure.

  • Incidence of recurrent stroke after PFO closure

    At 1, 6, and 12 months after the procedure.

  • Incidence of device-related thrombosis after PFO closure

    At 1, 6, and 12 months after the procedure.

  • +4 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • The participant expresses a desire to withdraw from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

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

Study Officials

  • Lijun Fu

    Shanghai Children's Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinyi Xu

CONTACT

+86 189308307563342@scmc.com.cn

Kai Wang

CONTACT

+86 1531792190330192@scmc.com.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 29, 2026

Study Start

December 30, 2025

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Start Date: 12 months after publication of the primary results End Date: No end date
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.

Locations

CN(11)