EArLy FeasibiLity Study Of the EdWards Transcatheter Atrial ShUnt System (ALT FLOW US)
The early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.
Data collected in this clinical study will include safety, function and effectiveness of the investigational system as well as up to 5 year clinical outcomes in patients with left heart failure and elevated left atrial pressure where PVD is either absent (no PH or isolated post-capillary PH, PVR = 3) or present (Combined pre- and post-capillary PH, PVR > 3).
Please use this link for further information:clinicaltrials.gov
Primary Investigator: Joseph Choo