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NCT05064709NARecruiting

Assessment of CCM in HF With Higher Ejection Fraction

Impulse Dynamics

Start Date

2/3/2022

Completion Date

2/1/2029

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%.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System

DEVICE

OPTIMIZER™ Smart Mini System

Interested in This Trial?

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Conditions

Heart FailureHeart Failure With Preserved Ejection FractionHeart Failure With Mid Range Ejection FractionHeart Failure With Moderately Reduced Ejection FractionDiastolic Heart Failure

Locations

Grandview Medical Group Research, LLC

Birmingham, Alabama 35243

United States

CardioVascular Associates of Mesa

Mesa, Arizona 85206

United States

Chan Heart Rhythm Institute

Mesa, Arizona 85206

United States

Southwest Cardiovascular Associates

Mesa, Arizona 85208

United States

Arizona Heart Rhythm

Phoenix, Arizona 85016

United States

Cardiovascular Consultants, Ltd

Phoenix, Arizona 85032

United States

HonorHealth

Scottsdale, Arizona 85258

United States

Pima Heart and Vascular

Tuscon, Arizona 85712

United States

John Muir Health

Concord, California 94520

United States

University of California San Diego

La Jolla, California 92093

United States

USC Keck School of Medicine

Los Angeles, California 90033

United States

Cedars Sinai Medical Center

Los Angeles, California 90048

United States

Valley Clinical Trials- Northridge

Northridge, California 91325

United States

Sequoia Hospital

Redwood City, California 94062

United States

University of California Davis Health

Sacramento, California 95817

United States

University of California, San Francisco

San Francisco, California 94143

United States

Nuvance Health - Danbury Hospital

Danbury, Connecticut 06810

United States

Hartford Healthcare

Hartford, Connecticut 06103

United States

HCA Florida JFK Hospital

Atlantis, Florida 33462

United States

Nouvelle Clinical Research LLC

Cutler Bay, Florida 33189

United States

Broward Health

Fort Lauderdale, Florida 33316

United States

Memorial Healthcare System

Hollywood, Florida 33021

United States

Baptist Health South Florida

Miami, Florida 33176

United States

NCA Research Institute - Florida

Naples, Florida 34102

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

Revival Clinical Research

Orlando, Florida 32807

United States

Tallahassee Research Institute

Tallahassee, Florida 32308

United States

Cleveland Clinic Foundation - Florida Weston Hospital

Weston, Florida 33326

United States

Piedmont Healthcare

Atlanta, Georgia 30309

United States

Franciscan Health Indianapolis

Indianapolis, Indiana 46237

United States

Ascension Medical Group St. Vincent

Indianapolis, Indiana 46260

United States

University of Iowa

Iowa City, Iowa 52242

United States

MercyOne Iowa Heart

West Des Moines, Iowa 50266

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Kansas City Cardiac Arrhythmia Research LLC

Overland Park, Kansas 66211

United States

Baptist Health Lexington

Lexington, Kentucky 40503

United States

Ochsner Clinic Foundation

New Orleans, Louisiana 70121

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

University of Michigan

Ann Arbor, Michigan 48113

United States

Henry Ford St. John Hospital

Detroit, Michigan 48236

United States

Ascension Providence Hospital

Southfield, Michigan 48075

United States

Trinity health- Michigan Heart

Ypsilanti, Michigan 48197

United States

Minneapolis Heart Institute at Abbott Northwestern Hospital

Minneapolis, Minnesota 55407

United States

North Mississippi Medical Center

Tupelo, Mississippi 38801

United States

St. Louis Heart and Vascular

Bridgeton, Missouri 63044

United States

St. Luke&#39;s Hospital

Chesterfield, Missouri 63017

United States

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

Kansas City, Missouri 64111

United States

Bryan Heart

Lincoln, Nebraska 68506

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198-5331

United States

Catholic Medical Center

Manchester, New Hampshire 03102

United States

Our Lady of Lourdes

Camden, New Jersey 08103

United States

Hackensack University Medical Center

Edison, New Jersey 08837

United States

Jersey Shore University Medical Center

Edison, New Jersey 08837

United States

Cooper Hospital- Cardiovascular Associates of Delaware Valley

Haddon Heights, New Jersey 08035

United States

Atlantic Health System- Morristown Medical Center

Morristown, New Jersey 07960

United States

Rutgers New Jersey Medical School

Piscataway, New Jersey 08854

United States

AtlantiCare Regional Medical Center

Pomona, New Jersey 08240

United States

Buffalo General

Buffalo, New York 14203

United States

Weill Cornell Medicine

New York, New York 10021

United States

Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC

Poughkeepsie, New York 12601

United States

Nuvance Health - Vassar brothers Medical Center

Poughkeepsie, New York 12601

United States

Sanger Heart and Vascular

Charlotte, North Carolina 28203

United States

TriHealth Bethesda

Cincinnati, Ohio 45202

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

OhioHealth Research Institute

Columbus, Ohio 43214

United States

Mercy Health- St. Vincent Medical Center LLC

Toledo, Ohio 43608

United States

Oklahoma Heart Institute

Tulsa, Oklahoma 74104

United States

St. Francis Hospital - Tulsa

Tulsa, Oklahoma 74136

United States

Providence Heart & Vascular

Portland, Oregon 97225

United States

Bryn Mawr Medical Specialists Association

Bryn Mawr, Pennsylvania 19010

United States

UPMC Pinnacle Harrisburg

Harrisburg, Pennsylvania 17110

United States

Penn State Hershey Medical City

Hershey, Pennsylvania 17033

United States

Lancaster General Hospital

Lancaster, Pennsylvania 17602

United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania 19104-6061

United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania 19107

United States

Temple University Hospital

Philadelphia, Pennsylvania 19140

United States

Allegheny General Hospital

Pittsburgh, Pennsylvania 15212

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213

United States

Tower Health Reading Hospital

Reading, Pennsylvania 19611

United States

WellSpan Health

York, Pennsylvania 17403

United States

Prisma Health Upstate

Greenville, South Carolina 29601

United States

Bon Secours Upstate Cardiology

Greenville, South Carolina 29607

United States

North Central Heart

Sioux Falls, South Dakota 57108

United States

The Stern Cardiovascular Foundation

Germantown, Tennessee 38138

United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas 78705

United States

Ascension Seton

Austin, Texas 78723

United States

Austin Heart

Austin, Texas 78756

United States

Baylor Scott and White Research Institute

Dallas, Texas 75204

United States

HCA Medical City Dallas

Dallas, Texas 75230

United States

Baylor Scott White- All Saints- Fort Worth

Fort Worth, Texas 76104

United States

Medical City Fort Worth Hospital

Fort Worth, Texas 76104

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Houston Methodist

Houston, Texas 77030

United States

Memorial Hermann Texas Medical Center

Houston, Texas 77030

United States

Heart Rhythm Specialists

McKinney, Texas 75070

United States

Baylor Scott and White- The Heart Hospital- Plano

Plano, Texas 75093

United States

Baylor Scott and White Research Institute - Round Rock

Round Rock, Texas 78665

United States

Methodist Hospital

San Antonio, Texas 78229

United States

Bon Secours St. Mary's

Richmond, Virginia 23114

United States

Bon Secours St. Mary's

Richmond, Virginia 23226

United States

Swedish Medical Center

Seattle, Washington 98122

United States

Peace Health

Vancouver, Washington 98664

United States