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Assessment of CCM in HF With Higher Ejection Fraction
NCT05064709 · Impulse Dynamics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction
About this study
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
Inclusion Criteria:
1. 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:
1. 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
Enrollment target: 1500 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2022-02-03
Estimated completion: 2029-02-01
Last updated: 2026-01-15
Interventions
Device: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini SystemDevice: OPTIMIZER™ Smart Mini System
Primary outcomes
- • Part 1 Efficacy Endpoint - Change in 6-minute walk distance (6MWD) from baseline to 6 months. (6 months)
- • Part 1 Efficacy Endpoint - Change in the health status from baseline to 6 months as assessed by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS). (6 months)
- • Part 1 Safety Endpoint - The incidence of Optimizer device- or procedure-related complications within the first 12 months after implant (12 months)
Sponsor
Impulse Dynamics · industry
Contacts & investigators
ContactRachael Riccitello · contact · aimhigher@impulsedynamics.com · 856-434-7981
InvestigatorJaved Butler, MD, MPH, MBA · principal_investigator, Baylor Scott and White Research Institute, Dallas, Texas
InvestigatorOussama Wazni, MD, MBA · principal_investigator, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA
All locations (112)
Grandview Medical Group Research, LLCRecruiting
Birmingham, Alabama, United States
The University of Alabama at BirminghamWithdrawn
Birmingham, Alabama, United States
CardioVascular Associates of MesaRecruiting
Mesa, Arizona, United States
Chan Heart Rhythm InstituteRecruiting
Mesa, Arizona, United States
Southwest Cardiovascular AssociatesRecruiting
Mesa, Arizona, United States
Banner Health- PhoenixWithdrawn
Phoenix, Arizona, United States
Arizona Heart RhythmRecruiting
Phoenix, Arizona, United States
Cardiovascular Consultants, LtdRecruiting
Phoenix, Arizona, United States
HonorHealthRecruiting
Scottsdale, Arizona, United States
Pima Heart and VascularRecruiting
Tuscon, Arizona, United States
John Muir HealthRecruiting
Concord, California, United States
Northbay Heart and VascularWithdrawn
Fairfield, California, United States
University of California San DiegoRecruiting
La Jolla, California, United States
USC Keck School of MedicineRecruiting
Los Angeles, California, United States
Cedars Sinai Medical CenterRecruiting
Los Angeles, California, United States
Valley Clinical Trials PasadenaWithdrawn
Northridge, California, United States
Valley Clinical Trials- NorthridgeRecruiting
Northridge, California, United States
Sequoia HospitalRecruiting
Redwood City, California, United States
University of California Davis HealthWithdrawn
Sacramento, California, United States
University of California, San FranciscoWithdrawn
San Francisco, California, United States
Nuvance Health - Danbury HospitalRecruiting
Danbury, Connecticut, United States
Hartford HealthcareRecruiting
Hartford, Connecticut, United States
HCA Florida JFK HospitalRecruiting
Atlantis, Florida, United States
Nouvelle Clinical Research LLCRecruiting
Cutler Bay, Florida, United States
Holy Cross HospitalWithdrawn
Fort Lauderdale, Florida, United States
Broward HealthRecruiting
Fort Lauderdale, Florida, United States
Memorial Healthcare SystemWithdrawn
Hollywood, Florida, United States
Baptist Health South FloridaRecruiting
Miami, Florida, United States
NCA Research Institute - FloridaWithdrawn
Naples, Florida, United States
AdventHealth OrlandoRecruiting
Orlando, Florida, United States
Revival Clinical ResearchRecruiting
Orlando, Florida, United States
Tallahassee Research InstituteWithdrawn
Tallahassee, Florida, United States
Cleveland Clinic Foundation - Florida Weston HospitalRecruiting
Weston, Florida, United States
Piedmont HealthcareWithdrawn
Atlanta, Georgia, United States
WellStar Health System, IncRecruiting
Marietta, Georgia, United States
Franciscan Health IndianapolisWithdrawn
Indianapolis, Indiana, United States
Ascension Medical Group St. VincentRecruiting
Indianapolis, Indiana, United States
University of IowaRecruiting
Iowa City, Iowa, United States
MercyOne Iowa HeartRecruiting
West Des Moines, Iowa, United States
University of Kansas Medical CenterRecruiting
Kansas City, Kansas, United States
Kansas City Cardiac Arrhythmia Research LLCRecruiting
Overland Park, Kansas, United States
Baptist Health LexingtonRecruiting
Lexington, Kentucky, United States
University of Kentucky Research FoundationRecruiting
Lexington, Kentucky, United States
Ochsner Clinic FoundationWithdrawn
New Orleans, Louisiana, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
University of MichiganRecruiting
Ann Arbor, Michigan, United States
Henry Ford St. John HospitalRecruiting
Detroit, Michigan, United States
Ascension Providence HospitalRecruiting
Southfield, Michigan, United States
Trinity health- Michigan HeartRecruiting
Ypsilanti, Michigan, United States
Minneapolis Heart Institute at Abbott Northwestern HospitalRecruiting
Minneapolis, Minnesota, United States
North Mississippi Medical CenterWithdrawn
Tupelo, Mississippi, United States
St. Louis Heart and VascularRecruiting
Bridgeton, Missouri, United States
St. Luke's HospitalWithdrawn
Chesterfield, Missouri, United States
St. Lukes Hospital Kansas City (Mid America Heart Institute)Recruiting
Kansas City, Missouri, United States
Bryan HeartRecruiting
Lincoln, Nebraska, United States
University of Nebraska Medical CenterWithdrawn
Omaha, Nebraska, United States
Catholic Medical CenterWithdrawn
Manchester, New Hampshire, United States
Our Lady of LourdesRecruiting
Camden, New Jersey, United States
Hackensack University Medical CenterWithdrawn
Edison, New Jersey, United States
Jersey Shore University Medical CenterWithdrawn
Edison, New Jersey, United States
Cooper Hospital- Cardiovascular Associates of Delaware ValleyRecruiting
Haddon Heights, New Jersey, United States
Atlantic Health System- Morristown Medical CenterRecruiting
Morristown, New Jersey, United States
Rutgers New Jersey Medical SchoolWithdrawn
Piscataway, New Jersey, United States
AtlantiCare Regional Medical CenterRecruiting
Pomona, New Jersey, United States
Buffalo GeneralRecruiting
Buffalo, New York, United States
Weill Cornell MedicineWithdrawn
New York, New York, United States
Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PCRecruiting
Poughkeepsie, New York, United States
Nuvance Health - Vassar brothers Medical CenterRecruiting
Poughkeepsie, New York, United States
Sanger Heart and VascularWithdrawn
Charlotte, North Carolina, United States
TriHealth BethesdaWithdrawn
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical CenterWithdrawn
Cleveland, Ohio, United States
Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
Ohio State University Wexner Medical CenterRecruiting
Columbus, Ohio, United States
OhioHealth Research InstituteRecruiting
Columbus, Ohio, United States
Mercy Health- St. Vincent Medical Center LLCWithdrawn
Toledo, Ohio, United States
Oklahoma Heart InstituteRecruiting
Tulsa, Oklahoma, United States
St. Francis Hospital - TulsaRecruiting
Tulsa, Oklahoma, United States
Providence Heart & VascularRecruiting
Portland, Oregon, United States
Bryn Mawr Medical Specialists AssociationRecruiting
Bryn Mawr, Pennsylvania, United States
UPMC Pinnacle HarrisburgWithdrawn
Harrisburg, Pennsylvania, United States
Penn State Hershey Medical CityRecruiting
Hershey, Pennsylvania, United States
Lancaster General HospitalWithdrawn
Lancaster, Pennsylvania, United States
Penn Presbyterian Medical CenterRecruiting
Philadelphia, Pennsylvania, United States
Hospital of the University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Thomas Jefferson University HospitalRecruiting
Philadelphia, Pennsylvania, United States
Temple University HospitalRecruiting
Philadelphia, Pennsylvania, United States
Allegheny General HospitalRecruiting
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical CenterRecruiting
Pittsburgh, Pennsylvania, United States
Tower Health Reading HospitalWithdrawn
Reading, Pennsylvania, United States
WellSpan HealthWithdrawn
York, Pennsylvania, United States
Prisma Health UpstateRecruiting
Greenville, South Carolina, United States
Bon Secours Upstate CardiologyWithdrawn
Greenville, South Carolina, United States
North Central HeartRecruiting
Sioux Falls, South Dakota, United States
The Stern Cardiovascular FoundationRecruiting
Germantown, Tennessee, United States
Texas Cardiac Arrhythmia Research FoundationWithdrawn
Austin, Texas, United States
Ascension SetonRecruiting
Austin, Texas, United States
Austin HeartRecruiting
Austin, Texas, United States
Baylor Scott and White Research InstituteRecruiting
Dallas, Texas, United States
HCA Medical City DallasWithdrawn
Dallas, Texas, United States
Baylor Scott White- All Saints- Fort WorthRecruiting
Fort Worth, Texas, United States
Medical City Fort Worth HospitalRecruiting
Fort Worth, Texas, United States
Baylor College of MedicineRecruiting
Houston, Texas, United States
Houston MethodistRecruiting
Houston, Texas, United States
Memorial Hermann Texas Medical CenterRecruiting
Houston, Texas, United States
Heart Rhythm SpecialistsRecruiting
McKinney, Texas, United States
Baylor Scott and White- The Heart Hospital- PlanoWithdrawn
Plano, Texas, United States
Baylor Scott and White Research Institute - Round RockRecruiting
Round Rock, Texas, United States
Methodist HospitalWithdrawn
San Antonio, Texas, United States
Bon Secours St. Mary'sRecruiting
Richmond, Virginia, United States
Bon Secours St. Mary'sRecruiting
Richmond, Virginia, United States
Swedish Medical CenterRecruiting
Seattle, Washington, United States
Peace HealthRecruiting
Vancouver, Washington, United States