CardioVascular Center for Research and Innovation (CVCRI)

Trial spotlight

Opening Holes in the Heart: A Novel Treatment for Specific a Type of Congestive Heart Failure known as Heart Failure with Preserved Ejection Fraction (HFpEF)  

Congestive heart failure affects nearly 8 million individuals in the United States alone. A subtype of heart failure known as heart failure with preserved ejection fraction (HFpEF) is particularly challenging to treat. Patients with HFpEF suffer from symptoms due to high pressures in the left atrium which leads to a buildup of fluid on the lungs.

We are currently recruiting patients with HFpEF for the REDUCE LAP-HF II study at Tufts Medical Center. This study evaluates the clinical efficacy and safety of the Inter-Atrial Shunt Device (IASD®, pictured to the left) System II for HFpEF patients with elevated left atrial pressure who remain symptomatic despite appropriate medical management. This intervention is performed by a globally recognized interventional cardiologist with expertise in structural heart disease (Carey Kimmelstiel, MD) during a standard catheter-based procedure. The IASD system II creates an 8mm opening between the left and right atria. This opening allows blood to flow from the high pressure left atrium to the low pressure right atrium, potentially reducing the pressure in the left atrium and lungs, especially during exertion.

This is a randomized trial, with 1:1 allocation between device implantation and a sham procedure, although subjects who are randomized to the sham procedure will be offered the device after 2 years of study participation, if they still meet inclusion criteria. Published results from REDUCE LAP-HF I demonstrate that the IASD system can reduce left-sided exercise pressures. The primary endpoint for REDUCE-LAP HF II is a composite of cardiovascular mortality, ischemic stroke and change in Kansas City Cardiomyopathy Questionnaire score between baseline and 6 months.

Key inclusion criteria

• Age is greater than or equal to 40
• LVEF is greater than or equal to 40% within the past 3 months, and with no prior LVEF < 30% in the last 5 years
• Chronic symptomatic Heart Failure documents by one or more of the following:
•   Current treatment with diuretics for >30 days
•   NYHA class II with a history of > NYHA class II
•   >1 HF hospital admission in the last 12 months; or BNP > 50 pg/mL in sinus rhythm, or >150 pg/mL in AF in last 6 months

Key exclusion criteria

• MI or percutaneous cardiac intervention in the past 3 months
• Cardiac Synchronization Therapy, stroke, TIA, DVT, or pulmonary emboli within the past 6 months
• Severe heart failure defined as one or more of the following
•   ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHSA Class IV HF
•   Cardiac index < 2.0 L/min/m2
•   Inotropic infusion (continuous or intermittent) for EF < 40% within the past 6 months
•   Patient is on the cardiac transplant waiting list
• Inability to perform 6 min walk test (distance < 50m) or 6 min walk test > 600m
• Presence of significant valve disease or clinically significant untreated carotid artery stenosis

We would be grateful for referrals of HFpEF patients who might be eligible for participation. Patients would only need to attend Tufts Medical Center for the research study visits and would continue routine clinical care with their existing cardiologist.

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