Safety and Efficacy of the Patent Foramen Ovale Suture System for the Closure of Patent Foramen Ovale

Summary

A prospective, multicenter, randomized controlled, non-inferiority clinical trial to evaluate the efficacy and safety of the patent foramen ovale suture system in the closure treatment of patent foramen ovale. A parallel controlled comparison will be conducted using the Amplatzer PFO Occluder manufactured by Abbott Medical Devices (Shanghai) co., Ltd. as the control device, to evaluate the safety and efficacy of the Patent Foramen Ovale Suture System in the closure treatment of patent foramen ovale.

Conditions

• Patent Foramen Ovale (PFO)

Interventions

DEVICE

Patent Foramen Ovale Suture System

In the experimental group, patients with patent foramen ovale (PFO) received PFO closure therapy using the Patent Foramen Ovale Suture System developed by Shenzhen Bihe Medical Co., Ltd.

DEVICE

Amplatzer PFO Occluder

In the control group, patients with patent foramen ovale (PFO) received PFO closure therapy using the Amplatzer PFO Occluder developed by Abbott Medical Devices(Shanghai) Co., Ltd.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital

  collaborator OTHER

• Fuwai Yunnan Cardiovascular Hospital

  collaborator OTHER

• The General Hospital of Northern Theater Command

  collaborator OTHER

• The First Hospital of Hebei Medical University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Meizhou People's Hospital

  collaborator OTHER

• Sichuan Provincial People's Hospital

  collaborator OTHER

• Lanzhou University Second Hospital

  collaborator OTHER

• Zibo Central Hospital

  collaborator OTHER_GOV

• Southwest Hospital, China

  collaborator OTHER

• Second Xiangya Hospital of Central South University

  collaborator OTHER

• Shenzhen Bihe Medical Co., Ltd

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-30

Primary Completion

2027-12-31

Completion

2032-07-31