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Assessment of CCM in HF With Higher Ejection Fraction
Sponsor: Impulse Dynamics
Summary
The AIM HIGHer Clinical Trial will evaluate the safety and efficacy of Cardiac Contractility Modulation (CCM) therapy in patients with heart failure with LVEF ≥40% and ≤70%.
Official title: Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2022-02-03
Completion Date
2029-02-01
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed ON for the first 18 months (blinded phase). CCM therapy will be programmed to deliver 7 one-hour phases of CCM therapy that are distributed equally over every 24-hour period. CCM will remain on following completion of the 18-month visit.
OPTIMIZER™ Smart Mini System
The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed OFF for the first 18 months (blinded phase). CCM will be turned on following completion of the 18-month visit.
Locations (67)
Grandview Medical Group Research, LLC
Birmingham, Alabama, United States
CardioVascular Associates of Mesa
Mesa, Arizona, United States
Southwest Cardiovascular Associates
Mesa, Arizona, United States
HonorHealth
Scottsdale, Arizona, United States
Pima Heart and Vascular
Tuscon, Arizona, United States
University of California San Diego
La Jolla, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Valley Clinical Trials- Northridge
Northridge, California, United States
Sequoia Hospital
Redwood City, California, United States
Nuvance Health - Danbury Hospital
Danbury, Connecticut, United States
Hartford Healthcare
Hartford, Connecticut, United States
Nouvelle Clinical Research LLC
Cutler Bay, Florida, United States
Baptist Health South Florida
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Clinical One Research
Orlando, Florida, United States
Cleveland Clinic Foundation - Florida Weston Hospital
Weston, Florida, United States
Northeast Georgia Health System
Gainesville, Georgia, United States
Ascension Medical Group St. Vincent
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
MercyOne Iowa Heart
West Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford St. John Hospital
Detroit, Michigan, United States
Ascension Providence Hospital
Southfield, Michigan, United States
Trinity health- Michigan Heart
Ypsilanti, Michigan, United States
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
St. Lukes Hospital Kansas City (Mid America Heart Institute)
Kansas City, Missouri, United States
Bryan Heart
Lincoln, Nebraska, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Our Lady of Lourdes
Camden, New Jersey, United States
Cooper Hospital- Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey, United States
Atlantic Health System- Morristown Medical Center
Morristown, New Jersey, United States
Rutgers New Jersey Medical School
Piscataway, New Jersey, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Buffalo General
Buffalo, New York, United States
Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
St. Francis Hospital - Tulsa
Tulsa, Oklahoma, United States
Providence Heart & Vascular
Portland, Oregon, United States
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania, United States
Penn State Hershey Medical City
Hershey, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Prisma Health Upstate
Greenville, South Carolina, United States
North Central Heart
Sioux Falls, South Dakota, United States
The Stern Cardiovascular Foundation
Germantown, Tennessee, United States
Ascension Seton
Austin, Texas, United States
Austin Heart
Austin, Texas, United States
Baylor Scott and White Research Institute
Dallas, Texas, United States
Baylor Scott White- All Saints- Fort Worth
Fort Worth, Texas, United States
Medical City Fort Worth Hospital
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist
Houston, Texas, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
Bon Secours St. Mary's
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Peace Health
Vancouver, Washington, United States