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 procedure.
Healthcare Professionals
A novel investigational therapy for heart failure
The Alleviant System enables a minimally invasive procedure, designed to reduce elevated left atrial pressure in the heart without leaving a permanent implant behind.
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.
No-implant Shunt
The Alleviant approach incorporates and builds upon an existing body of clinical evidence.
The Alleviant System is a novel, no-implant, minimally invasive therapy under investigation for patients suffering from heart failure. Designed to reduce elevated left atrial pressure, a primary contributor of heart failure symptoms, this therapy is currently being studied in patients with both preserved ejection fraction (HFpEF, ALLAY-HF) and reduced ejection fraction (HFrEF, ALLAY-HFrEF).
Early Clinical Trial Outcomes
Dr. Potter shares a patient's experience with the investigational device.
Early Clinical Results
Early outcomes with the Alleviant System
100%
Technical success and procedural safety.
Successful shunt creation following transseptal puncture with echocardiographic confirmation of left-to-right flow and confirmation of excised septal tissue with no procedure-related serious adverse cardiac events.¹ (n=38)
0%
Device-related serious adverse events.
No reported incidence of cardiovascular death or major cardiovascular-related adverse events, embolic stroke, systemic or pulmonary embolism, or any device-related or access site complications.¹ (n=38)
100%
Shunt patency and long-term durability.
Echocardiographic confirmation of left-to-right flow detected at one year and beyond.² (n=38)
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.
² Data on file at Alleviant Medical.
Hemodynamic Measures.
Pulmonary Capillary Wedge Pressure (PCWP)
Exercise intolerance is a defining characteristic of HFpEF. A marked rise in PCWP, a surrogate measure for left atrial pressure, during exertion is thought to be a key cause of exercise intolerance. At 1 month a 5.4 mmHg decrease in peak exercise PCWP was observed in 27 patients.¹
Functional Capacity.
New York Heart Association Class (NYHA)
The New York Heart Association Classification system is a simple and widely used tool that classifies patients with heart failure into one of four classes according to their degree of symptoms at rest and with activity. At 6 months, improvement in NYHA classification by one or more classes was reported in 66.7% of 26 patients.¹
Functional Capacity.
6-minute Walk Test (6MWT)
The 6-minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance walked in 6 minutes is used to measure changes in physical performance. At 6 months, 6MWT distance increased 37% across 23 patients (101 meters).¹ (p<0.001)
Quality of Life.
Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire is a 23-item self-administered questionnaire developed to independently measure the patient’s perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life within a 2-week recall period. The Overall Summary Score (OSS) includes the total symptom, physical function, social limitations and quality of life scores. At 6 months, 26 subjects reported an average 83% improvement in their KCCQ-OSS.¹ (p<0.001)
Hemodynamic Measures.
Pulmonary Capillary Wedge Pressure (PCWP)
Exercise intolerance is a defining characteristic of HFpEF. A marked rise in PCWP, a surrogate measure for left atrial pressure, during exertion is thought to be a key cause of exercise intolerance. At 1 month a 5.4 mmHg decrease in peak exercise PCWP was observed in 27 patients.¹
Functional Capacity.
New York Heart Association Class (NYHA)
The New York Heart Association Classification system is a simple and widely used tool that classifies patients with heart failure into one of four classes according to their degree of symptoms at rest and with activity. At 6 months, improvement in NYHA classification by one or more classes was reported in 66.7% of 26 patients.¹
Functional Capacity.
6-minute Walk Test (6MWT)
The 6-minute walk test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance walked in 6 minutes is used to measure changes in physical performance. At 6 months, 6MWT distance increased 37% across 23 patients (101 meters).¹ (p<0.001)
Quality of Life.
Kansas City Cardiomyopathy Questionnaire (KCCQ)
The Kansas City Cardiomyopathy Questionnaire is a 23-item self-administered questionnaire developed to independently measure the patient’s perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life within a 2-week recall period. The Overall Summary Score (OSS) includes the total symptom, physical function, social limitations and quality of life scores. At 6 months, 26 subjects reported an average 83% improvement in their KCCQ-OSS.¹ (p<0.001)
Clinical program
The investigational Alleviant System has received Breakthrough Device Designation from the US Food and Drug Administration (FDA). The device is now being evaluated in heart failure patients through the ALLAY-HF and ALLAY-HFrEF trials.
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