Status: Not yet recruiting
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.
Participants needed: 244
Trial details
Age: 18-65Biological sex: AllType: InterventionalSponsor: Shenzhen Bihe Medical Co., LtdUpdated: Jul 27, 2026
Eligibility criteria
The subject is aged between 18 and 65 years old; [+3]
Carotid atherosclerotic stenosis (stenosis degree >50% confirmed by ultrasound o... [+19]