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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
350
Creation of interatrial shunt
Cardiac imaging
Composite Primary Endpoint
The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.
Time frame: 12-Month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Keck Medical Center of USC
Los Angeles, California, United States
RECRUITINGUniversity California Los Angeles Medical Center
Los Angeles, California, United States
RECRUITINGUC Davis Medical Center
Sacramento, California, United States
RECRUITINGScripps Clinical Research Services
San Diego, California, United States
RECRUITINGUniversity of California San Francisco
San Francisco, California, United States
RECRUITINGDelray Medical Center
Delray Beach, Florida, United States
RECRUITINGAscension Sacred Heart
Pensacola, Florida, United States
RECRUITINGTampa General Hospital
Tampa, Florida, United States
RECRUITINGAtlanta VA Health Care System
Decatur, Georgia, United States
RECRUITINGMidwest Cardiovascular Institute
Naperville, Illinois, United States
RECRUITING...and 58 more locations