TCT-826 Prospective single center First In Human (FIH) clinical trial to evaluate the safety and effectiveness of a septal occluder with bioresorbable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO).

The objective of this trial is to investigate the effectiveness and safety of a new septal occluder with bioresorbable framework (Carag Bioresorbable Septal Occluder CBSO, CARAG AG, Switzerland) in the treatment of secundum ASD or PFO. Device closure of ASD/PFO is standard of care in most countries