International Follow-up Study on the Safety and Effectiveness of the Occlutech Atrial Flow Regulator Device for Adults with Heart Failure

What this Trial Is About

Researchers are evaluating the safety and performance of the Occlutech Atrial Flow Regulator device in patients with heart failure. This international, multicenter follow-up registry aims to identify unknown side effects and determine when this treatment is appropriate. The study focuses on patients with chronic symptomatic heart failure and monitors outcomes over a 36-month period after device implantation. Participants will receive the Occlutech Atrial Flow Regulator, which is an interatrial shunt device delivered through a catheter. Treatments and procedures follow clinical routine and device instructions, performed by experienced physicians at equipped centers. The study tracks device performance and cardiovascular events at 12, 24, and 36 months after implantation. During the study, participants will undergo assessments including vital signs, lab tests, quality of life questionnaires, ECGs, and echocardiograms. Researchers will measure major adverse cardiovascular and neurological events within one year, as well as heart function, exercise capacity, and medication changes over three years. Safety and efficacy will be closely monitored throughout the follow-up period.

The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients