Alleviant System
What is Heart Failure:
Heart failure occurs when the heart cannot pump blood properly. As a result, pressure builds within one of the heart’s chambers and may lead to heart failure symptoms that impair your quality of life.
Common Symptoms:
Symptoms that impair quality of life include:
- Shortness of breath during exertion (or at rest)
- Inability to perform daily activities (walking, climbing stairs)
- Fatigue and weakness
- Swelling in the legs, ankles, and feet
- Swelling in the belly area
Treatment of Heart Failure:
Although medications are available to help manage heart failure, many patients still experience heart failure symptoms, frequent hospitalization, and impaired quality of life.1-3
A minimally invasive procedure — Interatrial shunting — is being studied to treat certain types of heart failure. An interatrial shunt is intended to alleviate excess pressure within the heart. Clinical
studies have shown that interatrial shunting lowers pressure within the heart4 and may improve heart failure symptoms5 and quality of life.6,7
The Alleviant System is a medical device that creates an interatrial shunt through a single procedure without leaving a permanent cardiac implant in the heart.
To find out if interatrial shunting is an option for you, schedule an appointment and talk to your doctor.
ALLAY-HFrEF Clinical Study:
ALLAY-HFrEF is a clinical study designed to evaluate the safety and effectiveness of the Alleviant System in relieving heart failure symptoms and reducing heart failure hospitalizations.
Why Should I Participate?
Current treatment options for most types of heart failure are limited to medication, which may not adequately relieve symptoms. If you qualify and choose to join the ALLAY-HFrEF study, you will receive:
- Evaluations and monitoring of your heart failure condition from a team of specialists
- Study-related care and study-related procedures at no cost
- Ongoing follow-up evaluations (at no cost) over a 5-year period
- The opportunity to help advance new therapies that may improve the future management of heart failure
Who Should Participate?
Current treatment options for most types of heart failure are limited to medication, which may not adequately relieve symptoms.
If you qualify and choose to join the ALLAY-HFrEF study, you will receive:
- Evaluations and monitoring of your heart failure condition from a team of heart failure specialists.
- Study-related continued care and study-related procedures at no cost.
- Ongoing follow-up evaluations (at no cost) over a 5-year period.
- The opportunity to help advance new therapies that may improve the future management of heart failure.
What can you expect after the procedure?
- After the procedure, you will spend the night in the hospital and go home the next day.
- Short-term medication will be prescribed, unless you are already on a blood thinner. It is important to remain diligent with all prescribed heart failure and other medications.
- Once at home, it is important that you avoid strenuous physical activity for at least 2 weeks.
- Seek immediate medical attention if you experience a sudden increase in heart failure symptom frequency or severity.
Talk to Your Doctor About Heart Failure:
It is important to talk to your doctor about all your treatment options, especially if you continue to experience symptoms such as breathlessness and fatigue even while on heart
failure medications. The information provided should not be used as a substitute for talking with your doctor.
Potential Risks:
As with any investigational medical procedure, interatrial shunting has potential risks that should be reviewed with your doctor before deciding to participate.
1. Azizi Z, et al. Challenge of Optimizing Medical Therapy in Heart Failure: Unlocking the Potential of Digital Health and Patient Engagement. Journal of the American Heart Association. 2024;13(2):e030952.
2. McCullough PA, et al. Mortality and guideline-directed medical therapy in real-world heart failure patients with reduced ejection fraction. Clin Cardiol. 2021;44(9):1192-1198.
3. Lavalle C, et al. New Challenges in Heart Failure with Reduced Ejection Fraction: Managing Worsening Events. J Clin Med. 2023;12(22):6956.
4. Feldman, Ted, et al. “Transcatheter Interatrial Shunt Device for the Treatment of Heart Failure with Preserved Ejection Fraction (REDUCE LAP-HF I [Reduce
Elevated Left Atrial Pressure in Patients with Heart Failure]).” Circulation, vol.137, no. 4, 2018, pp. 364–375.
5. Stone et al, Interatrial ShuntTreatment for Heart Failure: The Randomized RELIEVE-HF Trial. Circulation, vol 150, no.24, 2024, 1931-1943.
6. Hasenfuß G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCELAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016;387(10025):1298-304.
7. ALLEVIATE-HF-1, HF-2 and HFrEF Clinical Studies. Data on file at Alleviant Medical.