New heart device aims to cut hospital stays for heart failure patients

NCT ID NCT03970343

Disease control Sponsor: Impulse Dynamics Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a device called the OPTIMIZER Smart, which is implanted in the chest to send mild electrical signals to the heart. It is for people with moderate-to-severe heart failure (NYHA class III) and a weakened heart pump (ejection fraction 25-45%). The goal is to see if the device is safe and can reduce heart-related hospital stays over 2 years compared to standard care. About 620 participants will be followed for up to 3 years.

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 620 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2020

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participants will represent a patient population with stable, systolic left ventricular dysfunction and moderate symptomatic heart failure despite guideline-directed medical therapy.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient provides written authorization and/or consent per institution and geographical requirements 2. Male or non-pregnant female, aged 18 or older 3. Left ventricular ejection fraction of 25-45% (inclusive, per site assessment) 4. NYHA Class III heart failure symptoms 5. Stated willingness to comply with all study procedures and availability for the duration of the study 6. Patient has been treated with guideline-directed medical therapy Exclusion Criteria: 1. Primary heart failure due to uncorrected mitral valve disease, or mitral valve repair or clip within 90 days of implant 2. IV inotropes, hemofiltration, or any form of positive inotropic support within 30 days prior to implant 3. Myocardial infarction within 90 days prior to implant 4. Undergone a CABG procedure within 90 days or a PTCA procedure within 30 days of implant 5. Prior heart transplant or ventricular assist device 6. Mechanical tricuspid valve 7. Receiving cardiac resynchronization therapy (CRT) or has a Class I indication for CRT implantation according to the ACCF/AHA/HRS guidelines for device-based therapy 8. Participating in a cardiac investigational study at the same time 9. Patient is in a vulnerable population (such as significant mental disability, prisoner) that in the judgement of the PI impedes ability to provide informed consent.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States
Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657, United States
Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States
Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States
Ascension Providence Park Hospital

Novi, Michigan, 38374, United States
Ascension St. Vincent

Indianapolis, Indiana, 46260, United States
Atrium Health

Charlotte, North Carolina, 28204, United States
Aurora Denver Cardiology Associates

Aurora, Colorado, 80012, United States
Aurora Research Institute

Milwaukee, Wisconsin, 53215, United States
Banner University Medical Center

Phoenix, Arizona, 85006, United States
Baptist Lexington

Lexington, Kentucky, 40503, United States
Baylor College of Medicine

Houston, Texas, 77030, United States
Bon Secours St. Mary's Hospital

Midlothian, Virginia, 23114, United States
Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010, United States
CAMC Clinical Trials Center

Charleston, West Virginia, 25304, United States
CHRISTUS Trinity Clinic Research

Tyler, Texas, 75702, United States
CardioVascular Associates of Mesa (CVAM)

Mesa, Arizona, 85206, United States
Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, 19067, United States
Cardiovascular Consultants of Philadelphia

Yardley, Pennsylvania, 19067, United States
Cardiovascular Institute of San Diego

Chula Vista, California, 91911, United States
Cardiovascular Society of Arizona

Phoenix, Arizona, 85006, United States
Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States
Centra Health- Lynchburg General Hospital

Lynchburg, Virginia, 24501, United States
Chan Heart Rhythm Institute (CHRI)

Mesa, Arizona, 85206, United States
Community Healthcare System

Munster, Indiana, 46321, United States
Cooper Hospital

Haddon Heights, New Jersey, 08035, United States
Downriver Heart and Vascular

Southgate, Michigan, 48195, United States
Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States
Florida Cardiology

Orlando, Florida, 32792, United States
Florida Heart Rhythm Specialist

Plantation, Florida, 33324, United States
Florida Memorial Hospital

Jacksonville, Florida, 32216, United States
Franciscan Physician Network

Indianapolis, Indiana, 46237, United States
HCA Chippenham Hospital

Richmond, Virginia, 23225, United States
Heart Rhythm Solutions

Davie, Florida, 33328, United States
Heart and Rhythm Institute of South Texas

San Antonio, Texas, 78229, United States
Honor Health

Scottsdale, Arizona, 85258, United States
Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
Logan Health

Kalispell, Montana, 59901, United States
Marshall Cardiology

Huntington, West Virginia, 25701, United States
Massachusetts General Hospital

Boston, Massachusetts, 02241, United States
MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States
Mercy Health - St. Vincent Medical Center

Toledo, Ohio, 43608, United States
Mid Valley Cardiology - Fresno

Fresno, California, 93720, United States
Minneapolis Heart Institute Foundation - Allina

Minneapolis, Minnesota, 55407, United States
Mission Health

Asheville, North Carolina, 28801, United States
Morristown Medical Center

Morristown, New Jersey, 07960, United States
Mount Carmel Research institute

Columbus, Ohio, 43213, United States
Mount Sinai Morningside

New York, New York, 10025, United States
NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States
NorthBay Health, Heart and Vascular

Fairfield, California, 94533, United States
OSF HealthCare Cardiovascular Institute

Rockford, Illinois, 61107, United States
OSF Healthcare Cardiovascular Institute

Peoria, Illinois, 61614, United States
OSF Healthcare Cardiovascular Institute

Urbana, Illinois, 61801, United States
Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States
Penn Medicine Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States
Penn Presybyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States
Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States
Piedmont Heart

Atlanta, Georgia, 30309, United States
Pima Heart and Vascular Research Center

Tucson, Arizona, 85712, United States
ProMedica Health Systems

Toledo, Ohio, 43606, United States
Reading Hospital

Reading, Pennsylvania, 19611, United States
Redmond Regional Medical Center

Rome, Georgia, 30165, United States
Regional Cardiac Arrythmia Inc.

Steubenville, Ohio, 43952, United States
Richmond VA Medical Center

Richmond, Virginia, 23249, United States
Rutgers Medical School

Newark, New Jersey, 07719, United States
South Orange County Cardiology Group

Laguna Hills, California, 92653, United States
Southwest Cardiovascular Associates

Mesa, Arizona, 85206, United States
St. Joseph Mercy Oakland

Pontiac, Michigan, 48341, United States
St. Louis Heart and Vascular

Bridgeton, Missouri, 63044, United States
St. Luke's University Health Network

Allentown, Pennsylvania, 18104, United States
Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States
Texan Procedure Center

El Paso, Texas, 79915, United States
Texas Cardiac Arrhythmia Research

Austin, Texas, 78705, United States
The Ohio State University

Columbus, Ohio, 43210, United States
Torrance Memorial Medical Center

Torrance, California, 90505, United States
TriHealth Hatton

Cincinnati, Ohio, 45242, United States
Trinity Health Michigan Heart

Ypsilanti, Michigan, 48197, United States
UPMC Heart and Vascular Institute

Pittsburgh, Pennsylvania, 15213, United States
UPMC Pinnacle Health

Harrisburg, Pennsylvania, 17011, United States
UT Health - Memorial Hermann Hospital

Houston, Texas, 77030, United States
UT Health San Antonio

San Antonio, Texas, 78229, United States
University Hospitals of Cleveland Medical Center

Cleveland, Ohio, 44106, United States
University of AZ - Sarver Heart Center

Tucson, Arizona, 85724, United States
University of Kentucky - Gill Heart & Vascular Institute Clinical Research

Lexington, Kentucky, 40536, United States
University of Southern California - Keck School of Medicine

Los Angeles, California, 90033, United States
VA North Texas Medical Center

Dallas, Texas, 75216, United States
Valley Clinical Trials

Northridge, California, 91325, United States
Valley Clinical Trials

Pasadena, California, 91105, United States
Valley Hospital

Ridgewood, New Jersey, 07450, United States
Virtua Health - Our Lady of Lourdes

Marlton, New Jersey, 08053, United States

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