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 Genders
- 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, Alabama 35243
Birmingham, Alabama 35243
CardioVascular Associates of Mesa
Mesa, Arizona 85206
Mesa, Arizona 85206
Southwest Cardiovascular Associates
Mesa, Arizona 85208
Mesa, Arizona 85208
Cardiovascular Consultants, Ltd
Phoenix, Arizona 85032
Phoenix, Arizona 85032
Pima Heart and Vascular
Tuscon, Arizona 85712
Tuscon, Arizona 85712
University of California San Diego
La Jolla, California 92093
La Jolla, California 92093
USC Keck School of Medicine
Los Angeles, California 90033
Los Angeles, California 90033
Cedars Sinai Medical Center
Los Angeles, California 90048
Los Angeles, California 90048
Valley Clinical Trials- Northridge
Northridge, California 91325
Northridge, California 91325
Sequoia Hospital
Redwood City, California 94062
Redwood City, California 94062
University of California, San Francisco
San Francisco, California 94143
San Francisco, California 94143
Hartford Healthcare
Hartford, Connecticut 06103
Hartford, Connecticut 06103
HCA Florida JFK Hospital
Atlantis, Florida 33462
Atlantis, Florida 33462
Nouvelle Clinical Research LLC
Cutler Bay, Florida 33189
Cutler Bay, Florida 33189
Baptist Health South Florida
Miami, Florida 33176
Miami, Florida 33176
Revival Clinical Research
Orlando, Florida 32807
Orlando, Florida 32807
Tallahassee Research Institute
Tallahassee, Florida 32308
Tallahassee, Florida 32308
Cleveland Clinic Foundation - Florida Weston Hospital
Weston, Florida 33326
Weston, Florida 33326
WellStar Health System, Inc
Marietta, Georgia 30062
Marietta, Georgia 30062
Ascension Medical Group St. Vincent
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
MercyOne Iowa Heart
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas 66211
Overland Park, Kansas 66211
Baptist Health Lexington
Lexington, Kentucky 40503
Lexington, Kentucky 40503
University of Kentucky Research Foundation
Lexington, Kentucky 40506
Lexington, Kentucky 40506
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Ascension Providence Hospital
Southfield, Michigan 48075
Southfield, Michigan 48075
Trinity health- Michigan Heart
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
St. Louis Heart and Vascular
Bridgeton, Missouri 63044
Bridgeton, Missouri 63044
St. Lukes Hospital Kansas City (Mid America Heart Institute)
Kansas City, Missouri 64111
Kansas City, Missouri 64111
University of Nebraska Medical Center
Omaha, Nebraska 68198-5331
Omaha, Nebraska 68198-5331
Cooper Hospital- Cardiovascular Associates of Delaware Valley
Haddon Heights, New Jersey 08035
Haddon Heights, New Jersey 08035
Atlantic Health System- Morristown Medical Center
Morristown, New Jersey 07960
Morristown, New Jersey 07960
Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Columbus, Ohio 43210
OhioHealth Research Institute
Columbus, Ohio 43214
Columbus, Ohio 43214
Oklahoma Heart Institute
Tulsa, Oklahoma 74104
Tulsa, Oklahoma 74104
St. Francis Hospital - Tulsa
Tulsa, Oklahoma 74136
Tulsa, Oklahoma 74136
Providence Heart & Vascular
Portland, Oregon 97225
Portland, Oregon 97225
Bryn Mawr Medical Specialists Association
Bryn Mawr, Pennsylvania 19010
Bryn Mawr, Pennsylvania 19010
Penn State Hershey Medical City
Hershey, Pennsylvania 17033
Hershey, Pennsylvania 17033
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania 19104-6061
Philadelphia, Pennsylvania 19104-6061
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Temple University Hospital
Philadelphia, Pennsylvania 19140
Philadelphia, Pennsylvania 19140
Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Prisma Health Upstate
Greenville, South Carolina 29601
Greenville, South Carolina 29601
The Stern Cardiovascular Foundation
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Baylor Scott and White Research Institute
Dallas, Texas 75204
Dallas, Texas 75204
Baylor Scott White- All Saints- Fort Worth
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Medical City Fort Worth Hospital
Fort Worth, Texas 76104
Fort Worth, Texas 76104
Memorial Hermann Texas Medical Center
Houston, Texas 77030
Houston, Texas 77030
Baylor Scott and White Research Institute - Round Rock
Round Rock, Texas 78665
Round Rock, Texas 78665
Methodist Hospital
San Antonio, Texas 78229
San Antonio, Texas 78229
Swedish Medical Center
Seattle, Washington 98122
Seattle, Washington 98122
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.