Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients with Chronic Heart Failure (ALLAY-HF)
ALLAY-HF is a prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF. Patients will be randomized in a 1:1 ratio to undergo the investigational device procedure or a sham-control procedure. The primary analysis will be performed after all study subjects have the opportunity to complete 12 months of follow-up. Regular follow-up visits are planned to occur through 5 years after the index procedure for all study subjects. Sham-control subjects will be offered an opportunity to cross-over after the 24-month follow-up and undergo the investigational device procedure if they meet study eligibility criteria at that time.
Sala Child & Family Support | NYU Langone Health
Hassenfeld Children’s Hospital at NYU Langone provides programs and services that support children and families.
Sala Family Advisory Council | NYU Langone Health
The Sala Family Advisory Council is a partner in advancing Hassenfeld Children’s Hospital’s model of patient- and family-centered care.
Sala Institute delivers family-centered pediatric care | NYU Langone Health
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Sala Institute for Child & Family Centered Care | NYU Langone Health
Sala Institute for Child and Family Centered Care leads support, quality, and safety efforts at Hassenfeld Children’s Hospital at NYU Langone.
Sala Patient & Family Faculty Program | NYU Langone Health
Members of the Sala Patient and Family Faculty Program at Hassenfeld Children’s Hospital at NYU Langone share their care experiences.
Sala Youth Advisory Council | NYU Langone Health
Members of the Sala Youth Advisory Council at Hassenfeld Children’s Hospital at NYU Langone share their experiences of being patients.
Salivary Gland Cancer | NYU Langone Health
Doctors at NYU Langone’s Perlmutter Cancer Center use surgery and radiation therapy—with or without chemotherapy—to manage salivary gland cancer.
Same-day urgent care via video visit | NYU Langone Health
Virtual Urgent Care appointments at NYU Langone Health are available to adults and children 5 and older for non-emergency medical concerns.
Samuels Orthopedic Immediate Care Center | NYU Langone Health
Experts at NYU Langone’s Samuels Orthopedic Immediate Care Center evaluate and treat children and adults who have acute orthopedic injuries.