Haraldur Bjarnason, M.D.

Closed for Enrollment

• Predicting the Safety and Effectiveness of Inferior Vena Cava Filters (PRESERVE) Rochester, Minn.

  PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 7 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll approximately 2,100 IVC filter subjects at up to 60 sites in the US. All treated subjects will be evaluated at procedure, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. The primary objective of this investigational device exemption (IDE) clinical investigation is to evaluate the safety and effectiveness of the commercially available IVC filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC filter.

• Registry of Angiovac Procedures In Detail Outcomes Database (RAPID) Rochester, Minn.

  The purpose of the RAPID registry is to collect information on the Angiovac procedure and Angiovac device used in the removal of fresh, soft thrombi or emboli during extracorporeal bypass for up to 6 hours.

• VIRTUS-OUS Safety and Efficacy of the Veniti Vici™ Venous Stent System (Veniti, Inc.) when used to Treat Clinically Significant Chronic Non-Malignant Obstruction of the Iliofemoral Venous Segment (VIRTUS) Rochester, Minn.

  The purpose of this study is to evaluate the safety and effectiveness of the Veniti Vici™ Venous Stent System in relation to pre-defined objective performance goals when used to treat a chronic non-cancerous blockage of the iliofemoral vein.