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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
700
Creation of interatrial shunt
Cardiac imaging
Composite Primary Endpoint
The primary endpoint is a composite of mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.
Time frame: 12-month
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University of Alabama
Birmingham, Alabama, United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
Pima Heart and Vascular
Tucson, Arizona, United States
Memorial Care Long Beach Medical Center
Long Beach, California, United States
UC Davis Medical Center
Sacramento, California, United States
Scripps Clinical Research Services
San Diego, California, United States
San Francisco VA
San Francisco, California, United States
University of California San Francisco
San Francisco, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Hartford Hospital
Hartford, Connecticut, United States
...and 87 more locations