Assessment of CCM in HF With Higher Ejection Fraction

Last updated: March 28, 2025
Sponsor: Impulse Dynamics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Chest Pain

Hyponatremia

Treatment

Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System

OPTIMIZER™ Smart Mini System

Clinical Study ID

NCT05064709
CA_CP_340
  • Ages > 18
  • All Genders

Study 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%.

Eligibility Criteria

Inclusion

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 anurgent heart failure visit requiring IV therapy within 6 months prior to studyconsent OR B. If there is no heart failure hospitalization within 12 months prior tostudy consent OR an urgent heart failure visit requiring IV therapy within 6 monthsprior to study consent, an elevated BMI-adjusted natriuretic peptide value must beachieved (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 aminimum of 30 days before providing study consent unless there is a documentedallergy or intolerance.

  • Eligibility for enrollment is maintained for patients on an SGLT2 inhibitorwithout prescribed concurrent standing loop diuretic therapy if investigatorsprovide instructions for a flexible PRN diuretic regimen (deemed appropriate bythe clinician in response to symptoms or weight gain) Note: Stable is definedas no more than a 100% increase or 50% decrease in dose within the last 30days. A one-time hold of diuretic dosing for 24 hours during the 30-day periodis allowed and not an exclusionary event.

Exclusion

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 theopinion of the investigator, contributes significantly to the primary symptoms ofshortness 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 30days prior to consent, in the hospital or an outpatient setting;

  13. Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects withactive/ongoing cardiac resynchronization therapy (CRT) implanted more than one yearago are eligible for inclusion if they are currently classified as NYHA class III orhigher.

  14. Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or haveundergone cardiac surgery within 90 days or a PCI procedure within 30 days prior tostudy 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 interferewith the interpretation of study data;

  20. Currently undergoing active chemotherapeutic and/or radiation treatment for canceror 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'sjudgement.

Study Design

Total Participants: 1500
Treatment Group(s): 2
Primary Treatment: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System
Phase:
Study Start date:
February 03, 2022
Estimated Completion Date:
February 01, 2026

Study 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.

Connect with a study center

  • Grandview Medical Group Research, LLC

    Birmingham, Alabama 35243
    United States

    Active - Recruiting

  • The University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • CardioVascular Associates of Mesa

    Mesa, Arizona 85206
    United States

    Active - Recruiting

  • Chan Heart Rhythm Institute

    Mesa, Arizona 85206
    United States

    Active - Recruiting

  • Southwest Cardiovascular Associates

    Mesa, Arizona 85208
    United States

    Active - Recruiting

  • Arizona Heart Rhythm

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Banner Health- Phoenix

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Cardiovascular Consultants, Ltd

    Phoenix, Arizona 85032
    United States

    Active - Recruiting

  • HonorHealth

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Pima Heart and Vascular

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Pima Heart and Vascular

    Tuscon, Arizona 85712
    United States

    Active - Recruiting

  • John Muir Health

    Concord, California 94520
    United States

    Active - Recruiting

  • Northbay Heart and Vascular

    Fairfield, California 94533
    United States

    Site Not Available

  • University of California San Diego

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Cedars Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • USC Keck School of Medicine

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Valley Clinical Trials Pasadena

    Northridge, California 91325
    United States

    Site Not Available

  • Valley Clinical Trials- Foothill Cardiology

    Northridge, California 91325
    United States

    Active - Recruiting

  • Valley Clinical Trials- Northridge

    Northridge, California 91325
    United States

    Active - Recruiting

  • Sequoia Hospital

    Redwood City, California 94062
    United States

    Active - Recruiting

  • University of California Davis Health

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Hartford Healthcare

    Hartford, Connecticut 06103
    United States

    Active - Recruiting

  • Nuvance Health

    Wilton, Connecticut 06897
    United States

    Active - Recruiting

  • HCA Florida JFK Hospital

    Atlantis, Florida 33462
    United States

    Active - Recruiting

  • Nouvelle Clinical Research LLC

    Cutler Bay, Florida 33189
    United States

    Active - Recruiting

  • Broward Health

    Fort Lauderdale, Florida 33316
    United States

    Active - Recruiting

  • Holy Cross Hospital

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Memorial Healthcare System

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Baptist Health South Florida

    Miami, Florida 33176
    United States

    Active - Recruiting

  • NCA Research Institute - Florida

    Naples, Florida 34102
    United States

    Site Not Available

  • AdventHealth Orlando

    Orlando, Florida 32803
    United States

    Active - Recruiting

  • Revival Clinical Research

    Orlando, Florida 32807
    United States

    Active - Recruiting

  • Tallahassee Research Institute

    Tallahassee, Florida 32308
    United States

    Active - Recruiting

  • Cleveland Clinic Foundation - Florida Weston Hospital

    Weston, Florida 33326
    United States

    Active - Recruiting

  • Piedmont Healthcare

    Atlanta, Georgia 30309
    United States

    Site Not Available

  • WellStar Health System, Inc

    Marietta, Georgia 30062
    United States

    Active - Recruiting

  • Ascension Medical Group St. Vincent

    Indianapolis, Indiana 46260
    United States

    Active - Recruiting

  • Franciscan Health Indianapolis

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • MercyOne Iowa Heart

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Kansas City Cardiac Arrhythmia Research LLC

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Baptist Health Lexington

    Lexington, Kentucky 40503
    United States

    Active - Recruiting

  • University of Kentucky Research Foundation

    Lexington, Kentucky 40506
    United States

    Active - Recruiting

  • Ochsner Clinic Foundation

    New Orleans, Louisiana 70121
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Ascension St. John

    Detroit, Michigan 48236
    United States

    Active - Recruiting

  • Ascension Providence Hospital

    Southfield, Michigan 48075
    United States

    Active - Recruiting

  • Trinity health- Michigan Heart

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Minneapolis Heart Institute at Abbott Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • North Mississippi Medical Center

    Tupelo, Mississippi 38801
    United States

    Site Not Available

  • St. Louis Heart and Vascular

    Bridgeton, Missouri 63044
    United States

    Active - Recruiting

  • St. Luke&#39;s Hospital

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • St. Luke's Hospital

    Chesterfield, Missouri 63017
    United States

    Active - Recruiting

  • St. Lukes Hospital Kansas City (Mid America Heart Institute)

    Kansas City, Missouri 64111
    United States

    Active - Recruiting

  • Bryan Heart

    Lincoln, Nebraska 68506
    United States

    Active - Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198-5331
    United States

    Active - Recruiting

  • Catholic Medical Center

    Manchester, New Hampshire 03102
    United States

    Active - Recruiting

  • Our Lady of Lourdes

    Camden, New Jersey 08103
    United States

    Active - Recruiting

  • Hackensack University Medical Center

    Edison, New Jersey 08837
    United States

    Site Not Available

  • Jersey Shore University Medical Center

    Edison, New Jersey 08837
    United States

    Site Not Available

  • Cooper Hospital- Cardiovascular Associates of Delaware Valley

    Haddon Heights, New Jersey 08035
    United States

    Active - Recruiting

  • Atlantic Health System- Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Rutgers New Jersey Medical School

    Piscataway, New Jersey 08854
    United States

    Site Not Available

  • Weill Cornell Medicine

    New York, New York 10021
    United States

    Site Not Available

  • Sanger Heart and Vascular

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • TriHealth Bethesda

    Cincinnati, Ohio 45202
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • OhioHealth Research Institute

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Mercy Health- St. Vincent Medical Center LLC

    Toledo, Ohio 43608
    United States

    Site Not Available

  • Oklahoma Heart Institute

    Tulsa, Oklahoma 74104
    United States

    Active - Recruiting

  • St. Francis Hospital - Tulsa

    Tulsa, Oklahoma 74136
    United States

    Active - Recruiting

  • Providence Heart & Vascular

    Portland, Oregon 97225
    United States

    Active - Recruiting

  • Bryn Mawr Medical Specialists Association

    Bryn Mawr, Pennsylvania 19010
    United States

    Active - Recruiting

  • UPMC Pinnacle Harrisburg

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • Penn State Hershey Medical City

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Lancaster General Hospital

    Lancaster, Pennsylvania 17602
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania 19104-6061
    United States

    Active - Recruiting

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Tower Health Reading Hospital

    Reading, Pennsylvania 19611
    United States

    Site Not Available

  • WellSpan Health

    York, Pennsylvania 17403
    United States

    Active - Recruiting

  • Prisma Health Upstate

    Greenville, South Carolina 29601
    United States

    Active - Recruiting

  • The Stern Cardiovascular Foundation

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Ascension Seton

    Austin, Texas 78723
    United States

    Active - Recruiting

  • Austin Heart

    Austin, Texas 78756
    United States

    Active - Recruiting

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas 78705
    United States

    Site Not Available

  • Baylor Scott and White Research Institute

    Dallas, Texas 75204
    United States

    Active - Recruiting

  • HCA Medical City Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Baylor Scott White- All Saints- Fort Worth

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Medical City Fort Worth Hospital

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Memorial Hermann Texas Medical Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Heart Rhythm Specialists

    McKinney, Texas 75070
    United States

    Active - Recruiting

  • Baylor Scott and White- The Heart Hospital- Plano

    Plano, Texas 75093
    United States

    Site Not Available

  • Baylor Scott and White Research Institute - Round Rock

    Round Rock, Texas 78665
    United States

    Active - Recruiting

  • Methodist Hospital

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Active - Recruiting

  • Peace Health

    Vancouver, Washington 98664
    United States

    Active - Recruiting

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