Assessment of CCM in HF With Higher Ejection Fraction
Purpose
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%.
Conditions
- Heart Failure
- Heart Failure With Preserved Ejection Fraction
- Heart Failure With Mid Range Ejection Fraction
- Heart Failure With Moderately Reduced Ejection Fraction
- Diastolic Heart Failure
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Signed and dated informed consent form; 2. Male or non-pregnant female, 18 years or older; 3. Diagnosed with symptomatic heart failure; 4. LVEF ≥40 and ≤70% (as assessed by site echo); 5. A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table 1 in Section 9.2.6) 6. Subjects must meet one of the following conditions: - Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance. - Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed appropriate by the clinician in response to symptoms or weight gain) Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event.
Exclusion Criteria
- Resting ventricular rate <50 or >110 bpm; 2. Resting systolic blood pressure <100 or ≥160 mmHg; 3. BMI greater than 46 4. Any severe valvular stenotic disease or any severe valvular regurgitation; 5. Mechanical tricuspid valve; 6. Complex congenital heart disease; 7. Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance; 8. Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT; 9. A KCCQ CCS score higher than 85; 10. Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy; 11. Unstable angina pectoris within 30 days prior to study consent; 12. Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting; 13. Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects with active/ongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as NYHA class III or higher. 14. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent; 15. Myocardial infarction within 90 days prior to study consent; 16. Prior heart transplant or ventricular assist device; 17. Planning to become pregnant during the study; 18. Dialysis (permanent) or GFR <15 ml/min/1.73m2; 19. Participating in another investigational drug or device study that may interfere with the interpretation of study data; 20. Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent; 21. Expected lifespan of less than 18 months from time of study consent; 22. Unable to follow through study protocol for any reasons in the investigator's judgement.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Multicenter, multi-national, randomized, quadruple-blind, sham controlled, 2-part, embedded IDE clinical trial
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- In addition to the subject, the entire site research team, the implanting physician, the Clinical Events Committee (CEC), and the clinical study monitors will all be blinded to the treatment assignment. Site research staff and Impulse Dynamics monitoring personnel will not have viewing rights to the randomization assignment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CCM Group (CCM ON) |
CCM therapy will be turned on in 2/3 of the subjects for the entire duration of the study. |
|
|
Sham Comparator Sham Group (CCM OFF) |
CCM therapy will be turned off in 1/3 of the subjects for the first 18 months of the study. After 18 months, CCM therapy will be turned on for the rest of the study duration. |
|
Recruiting Locations
Grandview Medical Group Research, LLC
Birmingham 4049979, Alabama 4829764 35243
Birmingham 4049979, Alabama 4829764 35243
CardioVascular Associates of Mesa
Mesa 5304391, Arizona 5551752 85206
Mesa 5304391, Arizona 5551752 85206
Chan Heart Rhythm Institute
Mesa 5304391, Arizona 5551752 85206
Mesa 5304391, Arizona 5551752 85206
Southwest Cardiovascular Associates
Mesa 5304391, Arizona 5551752 85208
Mesa 5304391, Arizona 5551752 85208
Arizona Heart Rhythm
Phoenix 5308655, Arizona 5551752 85016
Phoenix 5308655, Arizona 5551752 85016
Cardiovascular Consultants, Ltd
Phoenix 5308655, Arizona 5551752 85032
Phoenix 5308655, Arizona 5551752 85032
HonorHealth
Scottsdale 5313457, Arizona 5551752 85258
Scottsdale 5313457, Arizona 5551752 85258
Pima Heart and Vascular
Tuscon, Arizona 5551752 85712
Tuscon, Arizona 5551752 85712
John Muir Health
Concord 5339111, California 5332921 94520
Concord 5339111, California 5332921 94520
University of California San Diego
La Jolla 5363943, California 5332921 92093
La Jolla 5363943, California 5332921 92093
USC Keck School of Medicine
Los Angeles 5368361, California 5332921 90033
Los Angeles 5368361, California 5332921 90033
Cedars Sinai Medical Center
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90048
Valley Clinical Trials- Northridge
Northridge 5377985, California 5332921 91325
Northridge 5377985, California 5332921 91325
Sequoia Hospital
Redwood City 5386834, California 5332921 94062
Redwood City 5386834, California 5332921 94062
Nuvance Health - Danbury Hospital
Danbury 4832353, Connecticut 4831725 06810
Danbury 4832353, Connecticut 4831725 06810
Hartford Healthcare
Hartford 4835797, Connecticut 4831725 06103
Hartford 4835797, Connecticut 4831725 06103
HCA Florida JFK Hospital
Atlantis 4146372, Florida 4155751 33462
Atlantis 4146372, Florida 4155751 33462
Nouvelle Clinical Research LLC
Cutler Bay 6332309, Florida 4155751 33189
Cutler Bay 6332309, Florida 4155751 33189
Broward Health
Fort Lauderdale 4155966, Florida 4155751 33316
Fort Lauderdale 4155966, Florida 4155751 33316
Baptist Health South Florida
Miami 4164138, Florida 4155751 33176
Miami 4164138, Florida 4155751 33176
AdventHealth Orlando
Orlando 4167147, Florida 4155751 32803
Orlando 4167147, Florida 4155751 32803
Revival Clinical Research
Orlando 4167147, Florida 4155751 32807
Orlando 4167147, Florida 4155751 32807
Cleveland Clinic Foundation - Florida Weston Hospital
Weston 4178003, Florida 4155751 33326
Weston 4178003, Florida 4155751 33326
WellStar Health System, Inc
Marietta 4207783, Georgia 4197000 30062
Marietta 4207783, Georgia 4197000 30062
Ascension Medical Group St. Vincent
Indianapolis 4259418, Indiana 4921868 46260
Indianapolis 4259418, Indiana 4921868 46260
University of Iowa
Iowa City 4862034, Iowa 4862182 52242
Iowa City 4862034, Iowa 4862182 52242
MercyOne Iowa Heart
West Des Moines 4881346, Iowa 4862182 50266
West Des Moines 4881346, Iowa 4862182 50266
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Kansas City Cardiac Arrhythmia Research LLC
Overland Park 4276873, Kansas 4273857 66211
Overland Park 4276873, Kansas 4273857 66211
Baptist Health Lexington
Lexington 4297983, Kentucky 6254925 40503
Lexington 4297983, Kentucky 6254925 40503
University of Kentucky Research Foundation
Lexington 4297983, Kentucky 6254925 40506
Lexington 4297983, Kentucky 6254925 40506
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
University of Michigan
Ann Arbor 4984247, Michigan 5001836 48113
Ann Arbor 4984247, Michigan 5001836 48113
Henry Ford St. John Hospital
Detroit 4990729, Michigan 5001836 48236
Detroit 4990729, Michigan 5001836 48236
Ascension Providence Hospital
Southfield 5010636, Michigan 5001836 48075
Southfield 5010636, Michigan 5001836 48075
Trinity health- Michigan Heart
Ypsilanti 5015688, Michigan 5001836 48197
Ypsilanti 5015688, Michigan 5001836 48197
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis 5037649, Minnesota 5037779 55407
Minneapolis 5037649, Minnesota 5037779 55407
St. Louis Heart and Vascular
Bridgeton 4378391, Missouri 4398678 63044
Bridgeton 4378391, Missouri 4398678 63044
St. Lukes Hospital Kansas City (Mid America Heart Institute)
Kansas City 4393217, Missouri 4398678 64111
Kansas City 4393217, Missouri 4398678 64111
Bryan Heart
Lincoln 5072006, Nebraska 5073708 68506
Lincoln 5072006, Nebraska 5073708 68506
Our Lady of Lourdes
Camden 4501018, New Jersey 5101760 08103
Camden 4501018, New Jersey 5101760 08103
Cooper Hospital- Cardiovascular Associates of Delaware Valley
Haddon Heights 4502093, New Jersey 5101760 08035
Haddon Heights 4502093, New Jersey 5101760 08035
Atlantic Health System- Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
Morristown 5101427, New Jersey 5101760 07960
AtlantiCare Regional Medical Center
Pomona 4503665, New Jersey 5101760 08240
Pomona 4503665, New Jersey 5101760 08240
Buffalo General
Buffalo 5110629, New York 5128638 14203
Buffalo 5110629, New York 5128638 14203
Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC
Poughkeepsie 5132143, New York 5128638 12601
Poughkeepsie 5132143, New York 5128638 12601
Nuvance Health - Vassar brothers Medical Center
Poughkeepsie 5132143, New York 5128638 12601
Poughkeepsie 5132143, New York 5128638 12601
Ohio State University Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210
Columbus 4509177, Ohio 5165418 43210
OhioHealth Research Institute
Columbus 4509177, Ohio 5165418 43214
Columbus 4509177, Ohio 5165418 43214
Oklahoma Heart Institute
Tulsa 4553433, Oklahoma 4544379 74104
Tulsa 4553433, Oklahoma 4544379 74104
St. Francis Hospital - Tulsa
Tulsa 4553433, Oklahoma 4544379 74136
Tulsa 4553433, Oklahoma 4544379 74136
Providence Heart & Vascular
Portland 5746545, Oregon 5744337 97225
Portland 5746545, Oregon 5744337 97225
Bryn Mawr Medical Specialists Association
Bryn Mawr 5182063, Pennsylvania 6254927 19010
Bryn Mawr 5182063, Pennsylvania 6254927 19010
Penn State Hershey Medical City
Hershey 5193342, Pennsylvania 6254927 17033
Hershey 5193342, Pennsylvania 6254927 17033
Penn Presbyterian Medical Center
Philadelphia 4560349, Pennsylvania 6254927 19104-6061
Philadelphia 4560349, Pennsylvania 6254927 19104-6061
Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
Temple University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19140
Philadelphia 4560349, Pennsylvania 6254927 19140
Allegheny General Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15212
Pittsburgh 5206379, Pennsylvania 6254927 15212
University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15213
Pittsburgh 5206379, Pennsylvania 6254927 15213
Prisma Health Upstate
Greenville 4580543, South Carolina 4597040 29601
Greenville 4580543, South Carolina 4597040 29601
North Central Heart
Sioux Falls 5231851, South Dakota 5769223 57108
Sioux Falls 5231851, South Dakota 5769223 57108
The Stern Cardiovascular Foundation
Germantown 4624601, Tennessee 4662168 38138
Germantown 4624601, Tennessee 4662168 38138
Ascension Seton
Austin 4671654, Texas 4736286 78723
Austin 4671654, Texas 4736286 78723
Baylor Scott and White Research Institute
Dallas 4684888, Texas 4736286 75204
Dallas 4684888, Texas 4736286 75204
Baylor Scott White- All Saints- Fort Worth
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
Medical City Fort Worth Hospital
Fort Worth 4691930, Texas 4736286 76104
Fort Worth 4691930, Texas 4736286 76104
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Houston Methodist
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Memorial Hermann Texas Medical Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Heart Rhythm Specialists
McKinney 4710178, Texas 4736286 75070
McKinney 4710178, Texas 4736286 75070
Baylor Scott and White Research Institute - Round Rock
Round Rock 4724129, Texas 4736286 78665
Round Rock 4724129, Texas 4736286 78665
Bon Secours St. Mary's
Richmond 4781708, Virginia 6254928 23114
Richmond 4781708, Virginia 6254928 23114
Bon Secours St. Mary's
Richmond 4781708, Virginia 6254928 23226
Richmond 4781708, Virginia 6254928 23226
Swedish Medical Center
Seattle 5809844, Washington 5815135 98122
Seattle 5809844, Washington 5815135 98122
Peace Health
Vancouver 5814616, Washington 5815135 98664
Vancouver 5814616, Washington 5815135 98664
More Details
- NCT ID
- NCT05064709
- Status
- Recruiting
- Sponsor
- Impulse Dynamics
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.