Living with
Heart Failure?

Learn about a minimally-invasive investigational
treatment through the ALLAY Clinical Program

Millions of people worldwide are living with heart failure and its troubling symptoms. People with heart failure have difficulty breathing and often struggle with simple daily activities. Medications and devices that are intended to treat certain types of heart failure do not always work well in all patients. However, doctors are currently researching new therapies that may be able to help.

If you have heart failure, you may qualify for the ALLAY Clinical Program. The ALLAY trials are evaluating the Alleviant System - an investigational, minimally invasive treatment designed to improve heart failure symptoms without leaving a permanent implant in the heart.

What is Heart Failure?

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. Patients with heart failure experience frequent hospitalizations, shortness of breath and difficulty performing routine activities. Ultimately, these symptoms can take away what makes life feel special. Currently, interatrial shunt therapy is being evaluated for heart failure.

 

What is the Alleviant System?

The Alleviant System is an investigational, minimally invasive device designed to reduce excess pressure in the heart without leaving behind a permanent implant. The Alleviant System provides a therapy called interatrial shunting, which has been studied in recent years for treating heart failure. Clinical studies have shown that interatrial shunting lowers pressure within the heart and may improve heart failure symptoms and quality of life.1-7

The Alleviant procedure is performed by a qualified cardiologist using a non-surgical, catheter-based approach. Unlike other shunting procedures, the Alleviant approach does not leave behind a permanent implant in the heart.

The ALLAY Clinical Program

The Alleviant System is currently being offered at select treatment centers in the US, Canada, Europe, Australia, New Zealand and Israel through the ALLAY-HF Clinical Program. If you qualify and choose to participate in one of the ALLAY trials, 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

See If You Qualify

If heart failure is affecting your daily life, you may qualify for the ALLAY Clinical Program. The study is evaluating the Alleviant System - an investigational, non-surgical treatment designed to improve heart failure symptoms without leaving a permanent implant in the heart.

Complete the questionnaire below to see if you might qualify for the ALLAY Clinical Program, and to get connected directly with your local study center to learn more.

  1. 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, 2018, vol. 137, no. 4, pp. 364-375.
  2. Shah, Sanjiv J, et al. Atrial shunt device for heart failure with preserved and mildly reduced ejection fraction (REDUCE LAP-HF II): a randomised, multicentre, blinded, sham-controlled trial. The Lancet, 2023, vol. 399, iss. 10330, pp. 1130 – 1140.
  3. Stone, Gregg, et al, Interatrial Shunt Treatment for Heart Failure: The Randomized RELIEVE-HF Trial. Circulation, 2024, vol. 150, no.24, pp. 1931-1943.
  4. 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 (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase I trial. Lancet. 2016, vol. 387, no. 10025, pp. 1298-304.
  5. Rodés-Cabau, Josep, et al. Interatrial shunt therapy in advanced heart failure: Outcomes from the open-level cohort of the RELIEVE-HF trial. Euro. J. Heart Failure. 2024, vol. 26, iss. 4, pp. 1078-1089.
  6. Guimarães, Leonardo, et al. Interatrial shunt with the second-generation V-Wave system for patients with advanced chronic heart failure. EuroIntervention, 2020, vol. 15, pp. 1426-1428.
  7. ALLEVIATE-HF-1, -HF-2 and -HFrEF Clinical Studies. Data on file at Alleviant Medical.