Assessment of CCM in HF With Higher Ejection Fraction
Start Date
2/3/2022
Completion Date
2/1/2029
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%.
Detailed Description
The AIM HIGHer Clinical Trial is a prospective, multi-center, randomized, quadruple-blind, sham-controlled, two-part embedded trial of the safety and efficacy of CCM therapy delivered via the OPTIMIZER Smart Mini System in subjects with heart failure and an LVEF ≥40% and ≤70%. Subjects will be enrolled at approximately 150 sites in the US and 75 sites OUS. All subjects will undergo screening and baseline testing; all eligible subjects will be implanted with the Optimizer System. Subjects will be randomized in a 2:1 ratio to either CCM ON (CCM group) or to CCM OFF (Sham group). The trial will be blinded to the treatment assignment of the device for 18-months. Subjects in the Sham group will have CCM turned ON after completion of the 18-month study visit. Subjects enrolled during Part I (450 subjects) of the trial will continue follow-up through the end of Part II (up to an additional 1,050) and contribute data to both parts of the trial. Each part of the trial is distinguished by a separate scientific purpose. The specific purpose of each part is: Part I - Establish safety and effectiveness based on functional capacity and health status. Part II - Establish safety and effectiveness based on clinical outcome data.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
OPTIMIZER™ Smart Mini System
Conditions
Locations
Grandview Medical Group Research, LLC
Birmingham, Alabama 35243
United States
CardioVascular Associates of Mesa
Mesa, Arizona 85206
United States
Chan Heart Rhythm Institute
Mesa, Arizona 85206
United States
Southwest Cardiovascular Associates
Mesa, Arizona 85208
United States
Arizona Heart Rhythm
Phoenix, Arizona 85016
United States
Cardiovascular Consultants, Ltd
Phoenix, Arizona 85032
United States
HonorHealth
Scottsdale, Arizona 85258
United States
Pima Heart and Vascular
Tuscon, Arizona 85712
United States
John Muir Health
Concord, California 94520
United States
University of California San Diego
La Jolla, California 92093
United States
USC Keck School of Medicine
Los Angeles, California 90033
United States
Cedars Sinai Medical Center
Los Angeles, California 90048
United States
Valley Clinical Trials- Northridge
Northridge, California 91325
United States
Sequoia Hospital
Redwood City, California 94062
United States
University of California Davis Health
Sacramento, California 95817
United States
University of California, San Francisco
San Francisco, California 94143
United States
Nuvance Health - Danbury Hospital
Danbury, Connecticut 06810
United States
Hartford Healthcare
Hartford, Connecticut 06103
United States
HCA Florida JFK Hospital
Atlantis, Florida 33462
United States
Nouvelle Clinical Research LLC
Cutler Bay, Florida 33189
United States
Broward Health
Fort Lauderdale, Florida 33316
United States
Memorial Healthcare System
Hollywood, Florida 33021
United States
Baptist Health South Florida
Miami, Florida 33176
United States
NCA Research Institute - Florida
Naples, Florida 34102
United States
AdventHealth Orlando
Orlando, Florida 32803
United States
Revival Clinical Research
Orlando, Florida 32807
United States
Tallahassee Research Institute
Tallahassee, Florida 32308
United States
Cleveland Clinic Foundation - Florida Weston Hospital
Weston, Florida 33326
United States
Piedmont Healthcare
Atlanta, Georgia 30309
United States
Franciscan Health Indianapolis
Indianapolis, Indiana 46237
United States
Ascension Medical Group St. Vincent
Indianapolis, Indiana 46260
United States
University of Iowa
Iowa City, Iowa 52242
United States
MercyOne Iowa Heart
West Des Moines, Iowa 50266
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas 66211
United States
Baptist Health Lexington
Lexington, Kentucky 40503
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
University of Michigan
Ann Arbor, Michigan 48113
United States
Henry Ford St. John Hospital
Detroit, Michigan 48236
United States
Ascension Providence Hospital
Southfield, Michigan 48075
United States
Trinity health- Michigan Heart
Ypsilanti, Michigan 48197
United States
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
United States
North Mississippi Medical Center
Tupelo, Mississippi 38801
United States
St. Louis Heart and Vascular
Bridgeton, Missouri 63044
United States
St. Luke's Hospital
Chesterfield, Missouri 63017
United States
St. Lukes Hospital Kansas City (Mid America Heart Institute)
Kansas City, Missouri 64111
United States
Bryan Heart
Lincoln, Nebraska 68506
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198-5331
United States
Catholic Medical Center
Manchester, New Hampshire 03102
United States
Our Lady of Lourdes
Camden, New Jersey 08103
United States
Hackensack University Medical Center
Edison, New Jersey 08837
United States
Jersey Shore University Medical Center
Edison, New Jersey 08837
United States
Cooper Hospital- Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey 08035
United States
Atlantic Health System- Morristown Medical Center
Morristown, New Jersey 07960
United States
Rutgers New Jersey Medical School
Piscataway, New Jersey 08854
United States
AtlantiCare Regional Medical Center
Pomona, New Jersey 08240
United States
Buffalo General
Buffalo, New York 14203
United States
Weill Cornell Medicine
New York, New York 10021
United States
Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, New York 12601
United States
Nuvance Health - Vassar brothers Medical Center
Poughkeepsie, New York 12601
United States
Sanger Heart and Vascular
Charlotte, North Carolina 28203
United States
TriHealth Bethesda
Cincinnati, Ohio 45202
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Ohio State University Wexner Medical Center
Columbus, Ohio 43210
United States
OhioHealth Research Institute
Columbus, Ohio 43214
United States
Mercy Health- St. Vincent Medical Center LLC
Toledo, Ohio 43608
United States
Oklahoma Heart Institute
Tulsa, Oklahoma 74104
United States
St. Francis Hospital - Tulsa
Tulsa, Oklahoma 74136
United States
Providence Heart & Vascular
Portland, Oregon 97225
United States
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania 19010
United States
UPMC Pinnacle Harrisburg
Harrisburg, Pennsylvania 17110
United States
Penn State Hershey Medical City
Hershey, Pennsylvania 17033
United States
Lancaster General Hospital
Lancaster, Pennsylvania 17602
United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104-6061
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Temple University Hospital
Philadelphia, Pennsylvania 19140
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
Tower Health Reading Hospital
Reading, Pennsylvania 19611
United States
WellSpan Health
York, Pennsylvania 17403
United States
Prisma Health Upstate
Greenville, South Carolina 29601
United States
Bon Secours Upstate Cardiology
Greenville, South Carolina 29607
United States
North Central Heart
Sioux Falls, South Dakota 57108
United States
The Stern Cardiovascular Foundation
Germantown, Tennessee 38138
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705
United States
Ascension Seton
Austin, Texas 78723
United States
Austin Heart
Austin, Texas 78756
United States
Baylor Scott and White Research Institute
Dallas, Texas 75204
United States
HCA Medical City Dallas
Dallas, Texas 75230
United States
Baylor Scott White- All Saints- Fort Worth
Fort Worth, Texas 76104
United States
Medical City Fort Worth Hospital
Fort Worth, Texas 76104
United States
Baylor College of Medicine
Houston, Texas 77030
United States
Houston Methodist
Houston, Texas 77030
United States
Memorial Hermann Texas Medical Center
Houston, Texas 77030
United States
Heart Rhythm Specialists
McKinney, Texas 75070
United States
Baylor Scott and White- The Heart Hospital- Plano
Plano, Texas 75093
United States
Baylor Scott and White Research Institute - Round Rock
Round Rock, Texas 78665
United States
Methodist Hospital
San Antonio, Texas 78229
United States
Bon Secours St. Mary's
Richmond, Virginia 23114
United States
Bon Secours St. Mary's
Richmond, Virginia 23226
United States
Swedish Medical Center
Seattle, Washington 98122
United States
Peace Health
Vancouver, Washington 98664
United States