Spider PFO Closure System– Summary

    Name of the sponsor: Lifetech Scientific (Shenzhen) Co.,Ltd.

    Investigators and Study sites: Prof. Dr. Horst Sievert, Cardio Vascular Center Frankfurt, Germany

    Study Duration: Follow-up period: 12 months

    Study Population: 50 patients

    Study Design: A safety, performance, non-randomized, multi-center, open label, noncomparative,prospective interventional clinical investigation in subjects who are candidates for the implantation of a PFO Closure Device

    Primary Objectives: The primary objectives are to evaluate data on the safety and performance of the SpiderTM PFO Closure System. Safety: Adverse device effects during procedure and up to 12 months post-procedure. Performance: Ability to deliver the device to the PFO implant site.Device migration/malfunction.

    Secondary Objectives: User feedback concerning the handling of the SpiderTM PFO Closure System.

    Primary Endpoints: Safety: 1) Adverse device effects during the procedure up to the point of implanting the study device in the PFO, and during completion of the procedure. 2) Adverse device effects following the procedure through study completion. Performance: 1) Rate of accurate device placement. 2) Incidence of device migration/malfunction.

    Secondary Endpoints: 1) User feedback on handling concerning ease of preparation, delivery and placement of the device during the procedure. 2) Residual shunt after 6 months. 3) Adverse procedure (non-device) related events.

    Present situation: up to Feb.1st: The inclusion period is now finished, 50 patients were included in the study. One-month follow-up was completed in 49 patients, 6 months follow-up was completed in 20 patients, 9 months follow-up was completed in 10 patients.