Assessment of CCM in HF With Higher Ejection Fraction
Recruiting · NCT05064709 · Interventional (participants receive a specific treatment) · Lead sponsor: Impulse Dynamics
View the official record on ClinicalTrials.gov →Interventions studied
Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini SystemOPTIMIZER™ Smart Mini System
What this trial is about
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%.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Signed and dated informed consent form;
- Male or non-pregnant female, 18 years or older;
- Diagnosed with symptomatic heart failure;
- LVEF ≥40 and ≤70% (as assessed by site echo);
- 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)
- 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;
- Resting systolic blood pressure \<100 or ≥160 mmHg;
- BMI greater than 46
- Any severe valvular stenotic disease or any severe valvular regurgitation;
- Mechanical tricuspid valve;
- Complex congenital heart disease;
- 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;
- Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
- A KCCQ CCS score higher than 85;
- Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
- Unstable angina pectoris within 30 days prior to study consent;
- Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;
- 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.
- 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;
- Myocardial infarction within 90 days prior to study consent;
- Prior heart transplant or ventricular assist device;
- Planning to become pregnant during the study;
- Dialysis (permanent) or GFR \<15 ml/min/1.73m2;
- Participating in another investigational drug or device study that may interfere with the interpretation of study data;
- 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;
- Expected lifespan of less than 18 months from time of study consent;
- Unable to follow through study protocol for any reasons in the investigator's judgement.
Where it is running
60 locations listed across 31 US states.
- Grandview Medical Group Research, LLC - Birmingham, Alabama, United States
- CardioVascular Associates of Mesa - Mesa, Arizona, United States
- Chan Heart Rhythm Institute - Mesa, Arizona, United States
- Southwest Cardiovascular Associates - Mesa, Arizona, United States
- Arizona Heart Rhythm - Phoenix, Arizona, United States
- Cardiovascular Consultants, Ltd - Phoenix, Arizona, United States
- HonorHealth - Scottsdale, Arizona, United States
- Pima Heart and Vascular - Tuscon, Arizona, United States
- John Muir Health - Concord, California, 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
- University of California Davis Health - Sacramento, California, United States
- University of California, San Francisco - San Francisco, California, United States
- Nuvance Health - Danbury Hospital - Danbury, Connecticut, United States
- Hartford Healthcare - Hartford, Connecticut, United States
- HCA Florida JFK Hospital - Atlantis, Florida, United States
- Nouvelle Clinical Research LLC - Cutler Bay, Florida, United States
- Broward Health - Fort Lauderdale, Florida, United States
- Memorial Healthcare System - Hollywood, Florida, United States
- Baptist Health South Florida - Miami, Florida, United States
- NCA Research Institute - Florida - Naples, Florida, United States
- AdventHealth Orlando - Orlando, Florida, United States
- Revival Clinical Research - Orlando, Florida, United States
- Tallahassee Research Institute - Tallahassee, Florida, United States
- Cleveland Clinic Foundation - Florida Weston Hospital - Weston, Florida, United States
- Piedmont Healthcare - Atlanta, Georgia, United States
- Franciscan Health Indianapolis - Indianapolis, Indiana, 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
- Kansas City Cardiac Arrhythmia Research LLC - Overland Park, Kansas, United States
- Baptist Health Lexington - Lexington, Kentucky, United States
- Ochsner Clinic Foundation - New Orleans, Louisiana, 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
- North Mississippi Medical Center - Tupelo, Mississippi, United States
- St. Louis Heart and Vascular - Bridgeton, Missouri, United States
- St. Luke's Hospital - Chesterfield, Missouri, United States
- St. Lukes Hospital Kansas City (Mid America Heart Institute) - Kansas City, Missouri, United States
- Bryan Heart - Lincoln, Nebraska, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Catholic Medical Center - Manchester, New Hampshire, United States
- Our Lady of Lourdes - Camden, New Jersey, United States
- Hackensack University Medical Center - Edison, New Jersey, United States
- Jersey Shore University Medical Center - Edison, 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
- Weill Cornell Medicine - New York, New York, United States
- Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC - Poughkeepsie, New York, United States
Showing 60 of 105 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →