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RECRUITING

NCT05064709

Assessment of CCM in HF With Higher Ejection Fraction

Sponsor: Impulse Dynamics

View on ClinicalTrials.gov

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%.

Official title: Assessment of Implantable CCM in the Heart Failure Group With Higher Ejection Fraction

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1500

Start Date

2022-02-03

Completion Date

2029-02-01

Last Updated

2026-01-15

Healthy Volunteers

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

Interventions

DEVICE

Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System

The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed ON for the first 18 months (blinded phase). CCM therapy will be programmed to deliver 7 one-hour phases of CCM therapy that are distributed equally over every 24-hour period. CCM will remain on following completion of the 18-month visit.

DEVICE

OPTIMIZER™ Smart Mini System

The OPTIMIZER™ Smart Mini System will be implanted and CCM will be programmed OFF for the first 18 months (blinded phase). CCM will be turned on following completion of the 18-month visit.

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.

Locations (112)

Grandview Medical Group Research, LLC

Birmingham, Alabama, United States

The University of Alabama at Birmingham

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

Banner Health- Phoenix

Phoenix, 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

Northbay Heart and Vascular

Fairfield, 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 Pasadena

Northridge, 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

Holy Cross Hospital

Fort Lauderdale, 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

WellStar Health System, Inc

Marietta, 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

University of Kentucky Research Foundation

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

Nuvance Health - Vassar brothers Medical Center

Poughkeepsie, New York, United States

Sanger Heart and Vascular

Charlotte, North Carolina, United States

TriHealth Bethesda

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

OhioHealth Research Institute

Columbus, Ohio, United States

Mercy Health- St. Vincent Medical Center LLC

Toledo, Ohio, United States

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

St. Francis Hospital - Tulsa

Tulsa, Oklahoma, United States

Providence Heart & Vascular

Portland, Oregon, United States

Bryn Mawr Medical Specialists Association

Bryn Mawr, Pennsylvania, United States

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania, United States

Penn State Hershey Medical City

Hershey, Pennsylvania, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Tower Health Reading Hospital

Reading, Pennsylvania, United States

WellSpan Health

York, Pennsylvania, United States

Prisma Health Upstate

Greenville, South Carolina, United States

Bon Secours Upstate Cardiology

Greenville, South Carolina, United States

North Central Heart

Sioux Falls, South Dakota, United States

The Stern Cardiovascular Foundation

Germantown, Tennessee, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Ascension Seton

Austin, Texas, United States

Austin Heart

Austin, Texas, United States

Baylor Scott and White Research Institute

Dallas, Texas, United States

HCA Medical City Dallas

Dallas, Texas, United States

Baylor Scott White- All Saints- Fort Worth

Fort Worth, Texas, United States

Medical City Fort Worth Hospital

Fort Worth, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Methodist

Houston, Texas, United States

Memorial Hermann Texas Medical Center

Houston, Texas, United States

Heart Rhythm Specialists

McKinney, Texas, United States

Baylor Scott and White- The Heart Hospital- Plano

Plano, Texas, United States

Baylor Scott and White Research Institute - Round Rock

Round Rock, Texas, United States

Methodist Hospital

San Antonio, Texas, United States

Bon Secours St. Mary's

Richmond, Virginia, United States

Bon Secours St. Mary's

Richmond, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Peace Health

Vancouver, Washington, United States

Clinical Research Directory

Assessment of CCM in HF With Higher Ejection Fraction

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)