This is a research study to investigate the effectiveness and safety of a device for patients with heart failure with preserved ejection fraction (HFpEF). Patients with a left ventricular ejection fraction greater than or equal to 40%, symptoms of heart failure and elevated filling pressures on a test called a right heart catheterization may be eligible to enroll. Participation in this multicenter study involves being randomly assigned either to implantation of an Inter Atrial Shunt Device (IASD) System II, or a sham procedure. Participants will be followed by the Tufts Heart Failure Research Team at regular intervals, for a total of 5 years; however they will remain under the care of their usual Cardiologist. The IASD System II consists of a self-expanding metal structure that is placed into the wall between the upper chambers of the heart (right and left atria) to enable blood to move between these chambers. For HFpEF patients with high pressures in the left atrium, it is thought that enabling blood to move from the left atrium into the right atrium could improve symptoms such as shortness of breath. This device is not yet approved in the United States. Please look at the study website for more information (www.treatmyheartfailure.com).
Inclusion Criteria
- Chronic symptomatic Heart Failure (HF) documented by one or more of the following:
- New York Heart Association (NYHA) Class II/III/ambulatory class IV symptoms (Paroxysmal nocturnal dyspnea, Orthopnea, Dyspnea on mild or moderate exertion) at screening visit; or signs (Any rales post cough, Chest x-ray demonstrating pulmonary congestion,) within past 12 months;
- One hospital admission for which HF was a major component of the hospitalization within the 12 months prior to study entry (transient heart failure in the context of myocardial infarction does not qualify);
- On-going management with recommended heart failure medications and comorbidities for several months according to the guidelines (2012 ESC Guidelines for diagnosis and Treatment of Acute and Chronic Heart Failure).
- Left ventricular ejection fraction (obtained by echocardiography) ≥ 40%
- Elevated left ventricular filling pressures with a gradient compared to CVP documented by :
- PCWP or LVEDP at rest ≥ 15 mmHg, and greater than CVP, OR
- PCWP during supine bike exercise ≥ 25mm Hg, and CVP < 20 mm Hg
Exclusion Criteria
- Heart Failure due to specific diseases (such as amyloidosis, hypertrophic cardiomyopathy, sarcoidosis) or low ejection fraction.
- Inability to walk 50m
- Cardiac Surgery in the last 3 months
Study Requirements
This is a 5 year study with 7 visits in the first year and then 1 follow up visit every year following. Subjects will be blinded for the first 24 months. Subjects who find out they are in the control group and wish to get the procedure can crossover at the 24 month visit.
- Visit 1(2 hours): Screening procedures will be performed to make sure you are still eligible to get the device.
- Visit 2 (4 hours): This time, after the invasive homodynamic test you will have the device implanted during the cardiac catheterization procedure.
- Visit 3 (1 hour): Prior to discharge from the hospital, the study doctor may instruct you to take certain medications to reduce the chance of a developing a blood clot. You will also get a card that explains that you have an investigational device implanted in your heart. You should carry this card with you always, especially when you see a doctor.
- Visit 4 (2 hours): One month follow-up
- Visit 5 (30 min): Three-month follow-up
- Visit 6 (2 hours): Six-month follow-up
- Visit 7 (30 min): Twelve-month follow-up
- Annual follow up visits (2 hours) for 5 years after the procedure.
At these visits subjects will be asked to do some or all of the following:
- Physical Exam
- 6 minute walk test
- EKG
- Echocardiogram
- Blood Tests
- Complete Questionnaires
- Right Heart Catheterization
- Device Implant Procedure
