Study of a device to treat heart failure for patients with relatively normal pumping.

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.

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 40+

Eligibility Criteria

  • NYHA Class 3
  • 1 prior HF hospitalization within the last year.

What is involved

  • Surgical implant
  • 7 follow-ups
  • Blinded study.

Compensation

None

Contact Information

Study Coordinator
Amanda Morgan
Email
asmorgan@wakehealth.edu
Phone
336-713-4432
Principal Investigator
Dr. Bharathi Upadhya

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.