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

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.

NCT Number	NCT07726927
Lead Sponsor	Shenzhen Bihe Medical Co., Ltd Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital, Fuwai Yunnan Cardiovascular Hospital, The General Hospital of Northern Theater Command, The First Hospital of Hebei Medical University, Qilu Hospital of Shandong University, First Affiliated Hospital, Sun Yat-Sen University, Meizhou People's Hospital, Sichuan Provincial People's Hospital, Lanzhou University Second Hospital, Zibo Central Hospital, Southwest Hospital, China, Second Xiangya Hospital of Central South University
Conditions	Patent Foramen Ovale (PFO)
Enrollment	244 participants
Start Date	2026-06-30
Primary Completion	2027-12-31 (estimated)
Study Completion	2032-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-27