Procedure
How is the Alleviant shunt created?
Dr. Jacob Kriegel (Cardiothoracic Surgeon and Chief Medical Officer, Alleviant Medical) provides a step-by-step overview of the investigational procedure.
Heart Failure
What is heart failure?
Learn more about the Alleviant shunt and the clinical trial programs, ALLAY-HF and ALLAY-HFrEF.
Disease State
Heart failure occurs when the heart becomes weak or stiff and cannot pump blood properly throughout the body. Despite currently available treatments, many patients still experience symptoms that limit day-to-day life.
Currently, interatrial shunt therapy is being evaluated for heart failure.
Shortness of breath
Fatigue
Weakness
Swelling
Shortness of breath
Fatigue
Weakness
Swelling
Shortness of breath
Fatigue
Weakness
Swelling
Shortness of breath
Fatigue
Weakness
Swelling
Interatrial Shunt: A small passageway between the upper chambers of the heart
CAUTION - Investigational device - Not for sale. Limited by Federal (or United States) law to investigational use. Exclusively for clinical investigation and to be used by qualified investigators only.
Novel Investigational Treatment
An interatrial shunt is a small passageway between the upper chambers of the heart. It is an opening that is intended to reduce excess pressure buildup within the heart and lungs, which may reduce symptoms of heart failure that limit daily living and often result in hospitalization.
The Alleviant System is an investigational device currently being studied in patients suffering from heart failure who are symptomatic despite currently available therapies. The device is designed to create an interatrial shunt through a minimally invasive procedure without requiring open heart surgery.
Interatrial Shunt Therapy
What is interatrial shunting?
Dr. James Udelson (Chief of Cardiology, Tufts Medical Center, Boston, MA) explains investigational interatrial shunts for heart failure.
Early Clinical Outcomes
Dr. Rob Gooley shares a patient's experience with the investigational device.
Early clinical outcomes
67%
Reduction in HF symptoms.
After 6 months, 67% of patients (n=18/27) experienced fewer heart failure symptoms¹
93%
Improvement in quality of life.
After 6 months, 93% of patients (n=25/27) reported an improved quality of life¹
96%
Freedom from HF hospitalization.
After 6 months, 96% of patients (n=27/28) had no hospitalizations for heart failure¹
If you are experiencing heart failure symptoms, it is important to talk to your doctor about your treatment options, including participation in the ALLAY clinical trials program. As with any medical procedure, interatrial shunting has potential risks that should be discussed with your doctor before deciding to participate in a clinical trial with an investigational procedure.
¹ Udelson, J, Barker, C, Wilkins, G. et al. No-Implant Interatrial Shunt for HFpEF: 6-Month Outcomes From Multicenter Pilot Feasibility Studies. J Am Coll Cardiol HF. 2023 Aug, 11 (8_Part_2) 1121–1130.
¹ Udelson, J, Barker, C, Wilkins, G. et al. No-Implant Interatrial Shunt for HFpEF: 6-Month Outcomes From Multicenter Pilot Feasibility Studies. J Am Coll Cardiol HF. 2023 Aug, 11 (8_Part_2) 1121–1130.
Why Participate?
Why should heart failure patients consider participating in clinical studies?
Dr. Deepa Gopal (Cardiologist, Boston Medical Center, Boston, MA) explains the potential advantages of participating in the ALLAY trial program.
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No open heart surgery required.
Ongoing heart failure follow-up evaluations from a team of heart failure specialists over a 5-year period.
The opportunity to help advance new therapies that may improve the future management of heart failure.