Alleviant ALLAY-HF Study
Recruiting · NCT05685303 · Interventional (participants receive a specific treatment) · Lead sponsor: Alleviant Medical, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Alleviant ALV1 SystemSham-Control
What this trial is about
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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
- NYHA Class II, III or ambulatory IV
- Exercise right heart catheterization\*
- Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
- Exercise PVR \< 1.8 WU
- Ongoing stable GDMT
Exclusion criteria
- Advanced heart failure
- Presence of a pacemaker
- Evidence of right heart dysfunction
Where it is running
60 locations listed across 27 US states.
- Arizona Cardiovascular Research Center - Phoenix, Arizona, United States
- HonorHealth - Scottsdale, 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
- 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
- The Cardiac and Vascular Institute (TCAVI) - Gainesville, Florida, United States
- HCA Florida Memorial Hospital - Jacksonville, Florida, United States
- NCH Research Institute - Naples, Florida, United States
- Advent Health Orlando - Orlando, Florida, United States
- Ascension Sacred Heart - Pensacola, Florida, United States
- Atlanta VA Health Care System - Decatur, Georgia, United States
- Advocate Illinois Masonic Medical Center - Chicago, Illinois, United States
- Midwest Cardiovascular Institute - Naperville, Illinois, United States
- Prairie Education and Research Cooperative - Springfield, Illinois, United States
- Indiana University - Indianapolis, Indiana, United States
- St. Elizabeth Healthcare - Edgewood, Kentucky, United States
- Cardiovascular Institute of the South - Houma, Louisiana, United States
- University Medical Center New Orleans - New Orleans, Louisiana, United States
- Johns Hopkins Medical Institution - Baltimore, Maryland, United States
- Brigham and Women's Hospital - Boston, Massachusetts, United States
- Boston Medical Center - Boston, Massachusetts, United States
- Steward St. Elizabeth's Medical Center - Brighton, Massachusetts, United States
- VA Ann Arbor - Ann Arbor, Michigan, United States
- Ascension St. John Hospital - Detroit, Michigan, United States
- Minneapolis Heart Institute Foundation - Minneapolis, Minnesota, United States
- Washington University - St Louis - St Louis, Missouri, United States
- UMC of Southern Nevada - Las Vegas, Nevada, United States
- VA NY Harbor Healthcare System - New York, New York, United States
- New York University - New York, New York, United States
- Lenox Hill Hospital - New York, New York, United States
- St. Francis Hospital - Roslyn, New York, United States
- Stony Brook Medicine - Stony Brook, New York, United States
- Mission Hospital - Asheville, North Carolina, United States
- Duke University Hospital - Durham, North Carolina, United States
- NC Heart and Vascular Research - Raleigh, North Carolina, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- ProMedica Toledo Hospital - Toledo, Ohio, United States
- South Oklahoma Heart Research, LLC. - Oklahoma City, Oklahoma, United States
- Providence St. Vincent's Medical Center - Portland, Oregon, United States
- Pinnacle Health Cardiovascular Institute - Harrisburg, Pennsylvania, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- Prisma Health - Midlands - Colombia, South Carolina, United States
- Monument Health - Rapid City, South Dakota, United States
- Stern Cardiovascular Foundation - Germantown, Tennessee, United States
- Tennova Healthcare - Turkey Creek Medical Center - Knoxville, Tennessee, United States
- Hendrick Health - Abilene, Texas, United States
- Austin Heart - Austin, Texas, United States
- UT Southwestern - Dallas, Texas, United States
- Baylor Scott & White Research Institute - Plano, Texas, United States
- Waco Cardiology - Waco, Texas, United States
- University of Washington - Seattle, Washington, United States
- Advocate Aurora Health/Aurora Research Institute - Milwaukee, Wisconsin, United States
- OLV Hospital - Aalst, Belgium
- ZAS Middelheim - Antwerp, Belgium
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- Barcelona Hospital del Mar - Barcelona, Spain
Showing 60 of 93 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →