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RECRUITING
NCT05064709
NA

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

2026-10-23

Healthy Volunteers

No

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.

Locations (67)

Grandview Medical Group Research, LLC

Birmingham, Alabama, United States

CardioVascular Associates of Mesa

Mesa, Arizona, United States

Southwest Cardiovascular Associates

Mesa, Arizona, United States

HonorHealth

Scottsdale, Arizona, United States

Pima Heart and Vascular

Tuscon, Arizona, 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

Nuvance Health - Danbury Hospital

Danbury, Connecticut, United States

Hartford Healthcare

Hartford, Connecticut, United States

Nouvelle Clinical Research LLC

Cutler Bay, Florida, United States

Baptist Health South Florida

Miami, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

Clinical One Research

Orlando, Florida, United States

Cleveland Clinic Foundation - Florida Weston Hospital

Weston, Florida, United States

Northeast Georgia Health System

Gainesville, Georgia, 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

Baptist Health Lexington

Lexington, Kentucky, 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

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

Kansas City, Missouri, United States

Bryan Heart

Lincoln, Nebraska, United States

Catholic Medical Center

Manchester, New Hampshire, United States

Our Lady of Lourdes

Camden, 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

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

Poughkeepsie, New York, 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

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

Penn State Hershey Medical City

Hershey, 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

Prisma Health Upstate

Greenville, South Carolina, United States

North Central Heart

Sioux Falls, South Dakota, United States

The Stern Cardiovascular Foundation

Germantown, Tennessee, United States

Ascension Seton

Austin, Texas, United States

Austin Heart

Austin, Texas, United States

Baylor Scott and White Research Institute

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

Bon Secours St. Mary's

Richmond, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

Peace Health

Vancouver, Washington, United States