Heart Failure
Conditions
Brief summary
Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.
Interventions
DEVICEAlleviant ALV1 System
Creation of interatrial shunt
OTHERSham-Control
Cardiac imaging
Sponsors
Alleviant Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* LVEF ≤ 40% * NYHA class II, III or ambulatory IV HF * Receiving optimal, maximally tolerated, stable GDMT
Exclusion criteria
* Advanced heart failure * Life-expectancy \< 12 months * Evidence of right heart dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite Primary Endpoint | 12-Month | The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events. |
Countries
Australia, Belgium, Canada, Georgia, Greece, Israel, New Zealand, Poland, Spain, United States
Contacts
CONTACTStacia Kraus
PRINCIPAL_INVESTIGATORGregg Stone
Icahn School of Medicine at Mount Sinai
PRINCIPAL_INVESTIGATORJames Udelson
Tufts Medical Center
Outcome results
None listed