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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Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
ACTIVE_NOT_RECRUITINGHonorHealth
Scottsdale, Arizona, United States
TERMINATEDPima Heart and Vascular
Tucson, Arizona, United States
RECRUITINGMemorial Care Long Beach Medical Center
Long Beach, 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
RECRUITINGSanta Barbara Cottage Hospital
Santa Barbara, California, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
TERMINATEDThe Cardiac and Vascular Institute (TCAVI)
Gainesville, Florida, United States
RECRUITING...and 83 more locations