The purpose of this study is to evaluate the potential effectiveness, outcomes, and safety (before, during, and after study procedures) of the investigational device in the treatment of subjects with heart failure symptoms and relatively normal pumping of the heart. The device is called the IASD system II and it is permanently implanted in the heart to reduce in the increased pressure by creating a small opening between the two upper chambers of the heart. It will be a randomized, single blind (subject) trial. Subjects will be followed for two years and then annually for 3 years for a total of 5 years after implantation.
This is a study in which subjects who have heart failure and normal heart pumping function are enrolled in a weight management program. The study will examine the subject's symptoms, exercise capacity and bloodwork to see if there is improvement while on the weight management program and as they transition to a healthly diet and lifestyle.