What we are studying
The study doctor has determined that the health problems and symptoms you have may be due to an increase in the pressure of one of the two upper chambers of your heart, called the left atrium. This increased pressure can cause a variety of health problems including tiredness, difficulty breathing, a reduced ability to exercise, and the need to be hospitalized.
This study is evaluating an investigational device called the IASD System II. The device is permanently implanted in the heart and is designed to reduce the increased pressure described above by creating a small opening between the two upper chambers of your heart. If the investigational device relieves the pressure in your heart at rest or during physical activity, it may reduce some or all of the symptoms you are experiencing.