An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure

The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms. The primary goal is to determine if the device is safe to use. The findings from this study may be used to refine the intended patient population, the design of the device, or develop a subsequent randomized study.

This is a prospective, multicenter, single-arm early feasibility study (EFS) to evaluate the safety of the InterShunt PAS-C System in subjects with heart failure, and the feasibility of PAS-C to improve heart failure related symptoms. The device is used to create an interatrial shunt by removing septal tissue to reduce left atrial pressure. There is no permanent implant. Enrollment will include 20 subjects with documented heart failure who may benefit from the reduction of left atrial pressure. The primary objective of this study is to characterize the safety of using the PAS-C System by evaluating the proportion of subjects who experience a major adverse cardiac or cerebrovascular event or systemic embolization through one month after the procedure. The findings from this study will be used to develop a subsequent pivotal study.