Alleviant ALLAY-HFrEF Study
- Conditions
- Heart Failure
- Registration Number
- NCT06812533
- Lead Sponsor
- Alleviant Medical, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 350
- LVEF ≤ 40%
- NYHA class II, III or ambulatory IV HF
- Receiving optimal, maximally tolerated, stable GDMT
- Advanced heart failure
- Life-expectancy < 12 months
- Evidence of right heart dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (21)
University of California San Francisco
🇺🇸San Francisco, California, United States
Atlanta VA Health Care System
🇺🇸Decatur, Georgia, United States
Midwest Cardiovascular Institute
🇺🇸Naperville, Illinois, United States
University Medical Center New Orleans
🇺🇸New Orleans, Louisiana, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Washington University - St Louis
🇺🇸Saint Louis, Missouri, United States
Stony Brook Medicine
🇺🇸New York, New York, United States
NC Heart and Vascular Research
🇺🇸Raleigh, North Carolina, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Harrisburg, Pennsylvania, United States
Scroll for more (11 remaining)University of California San Francisco🇺🇸San Francisco, California, United States