Heart device trial aims to boost function in patients with preserved pumping ability

NCT ID NCT05064709

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

First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tests a small implanted device that sends gentle electrical signals to strengthen heart contractions in people with heart failure whose hearts still pump fairly well (ejection fraction 40-70%). Researchers will compare the device to a sham (inactive) implant in 1,500 participants to see if it improves walking distance and quality of life over 6-18 months. The goal is to offer a new option for managing heart failure symptoms without needing lifelong medication changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Cardiac Contractility Modulation (CCM) therapy via an implanted device (OPTIMIZER Smart Mini System)
What this could lead to: If successful, this could offer a new treatment option for heart failure patients with higher ejection fraction, improving their ability to exercise and overall well-being.
What could go wrong: This is a large trial, but the device requires surgery and carries risks like infection or device-related complications. It may not work for everyone, and benefits might be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

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

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,500 people

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

Started

Feb 2022

Expected to finish

Feb 2029

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.

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. 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.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure heart failure

As listed by the trial registrant

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

Diastolic heart failure Heart failure Heart failure with mid range ejection fraction Heart failure with moderately reduced ejection fraction Heart failure with preserved ejection fraction

How to take part

Only the study team decides who joins. These are the ways to reach them.

The study's own enquiry address

This study publishes an address for enquiries. See it below .
The places running it

76 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Show contact details

Locations

AdventHealth Orlando
RECRUITING

Orlando, Florida, 32803, United States
Allegheny General Hospital
RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Arizona Heart Rhythm
RECRUITING

Phoenix, Arizona, 85016, United States
Ascension Medical Group St. Vincent
RECRUITING

Indianapolis, Indiana, 46260, United States
Ascension Providence Hospital
RECRUITING

Southfield, Michigan, 48075, United States
Ascension Seton
RECRUITING

Austin, Texas, 78723, United States
AtlantiCare Regional Medical Center
RECRUITING

Pomona, New Jersey, 08240, United States
Atlantic Health System- Morristown Medical Center
RECRUITING

Morristown, New Jersey, 07960, United States
Austin Heart
RECRUITING

Austin, Texas, 78756, United States
Baptist Health Lexington
RECRUITING

Lexington, Kentucky, 40503, United States
Baptist Health South Florida
RECRUITING

Miami, Florida, 33176, United States
Baylor College of Medicine
RECRUITING

Houston, Texas, 77030, United States
Baylor Scott White- All Saints- Fort Worth
RECRUITING

Fort Worth, Texas, 76104, United States
Baylor Scott and White Research Institute
RECRUITING

Dallas, Texas, 75204, United States
Baylor Scott and White Research Institute - Round Rock
RECRUITING

Round Rock, Texas, 78665, United States
Baylor Scott and White- The Heart Hospital- Plano
WITHDRAWN

Plano, Texas, 75093, United States
Bon Secours St. Mary's
RECRUITING

Richmond, Virginia, 23114, United States
Bon Secours St. Mary's
RECRUITING

Richmond, Virginia, 23226, United States
Bon Secours Upstate Cardiology
WITHDRAWN

Greenville, South Carolina, 29607, United States
Broward Health
RECRUITING

Fort Lauderdale, Florida, 33316, United States
Bryan Heart
RECRUITING

Lincoln, Nebraska, 68506, United States
Bryn Mawr Medical Specialists Association
RECRUITING

Bryn Mawr, Pennsylvania, 19010, United States
Buffalo General
RECRUITING

Buffalo, New York, 14203, United States
CardioVascular Associates of Mesa
RECRUITING

Mesa, Arizona, 85206, United States
Cardiovascular Consultants, Ltd
RECRUITING

Phoenix, Arizona, 85032, United States
Catholic Medical Center
WITHDRAWN

Manchester, New Hampshire, 03102, United States
Cedars Sinai Medical Center
RECRUITING

Los Angeles, California, 90048, United States
Chan Heart Rhythm Institute
RECRUITING

Mesa, Arizona, 85206, United States
Cleveland Clinic Foundation
RECRUITING

Cleveland, Ohio, 44195, United States
Cleveland Clinic Foundation - Florida Weston Hospital
RECRUITING

Weston, Florida, 33326, United States
Cooper Hospital- Cardiovascular Associates of Delaware Valley
RECRUITING

Haddon Heights, New Jersey, 08035, United States
Franciscan Health Indianapolis
WITHDRAWN

Indianapolis, Indiana, 46237, United States
Grandview Medical Group Research, LLC
RECRUITING

Birmingham, Alabama, 35243, United States
HCA Florida JFK Hospital
RECRUITING

Atlantis, Florida, 33462, United States
HCA Medical City Dallas
WITHDRAWN

Dallas, Texas, 75230, United States
Hackensack University Medical Center
WITHDRAWN

Edison, New Jersey, 08837, United States
Hartford Healthcare
RECRUITING

Hartford, Connecticut, 06103, United States
Heart Rhythm Specialists
RECRUITING

McKinney, Texas, 75070, United States

Contact Email: •••••@•••••
Henry Ford St. John Hospital
RECRUITING

Detroit, Michigan, 48236, United States
HonorHealth
RECRUITING

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

Philadelphia, Pennsylvania, 19104, United States
Houston Methodist
RECRUITING

Houston, Texas, 77030, United States
Jersey Shore University Medical Center
WITHDRAWN

Edison, New Jersey, 08837, United States
John Muir Health
RECRUITING

Concord, California, 94520, United States
Kansas City Cardiac Arrhythmia Research LLC
RECRUITING

Overland Park, Kansas, 66211, United States
Lancaster General Hospital
WITHDRAWN

Lancaster, Pennsylvania, 17602, United States
Massachusetts General Hospital
RECRUITING

Boston, Massachusetts, 02114, United States
Medical City Fort Worth Hospital
RECRUITING

Fort Worth, Texas, 76104, United States
Memorial Healthcare System
WITHDRAWN

Hollywood, Florida, 33021, United States
Memorial Hermann Texas Medical Center
RECRUITING

Houston, Texas, 77030, United States
Mercy Health- St. Vincent Medical Center LLC
WITHDRAWN

Toledo, Ohio, 43608, United States
MercyOne Iowa Heart
RECRUITING

West Des Moines, Iowa, 50266, United States
Methodist Hospital
WITHDRAWN

San Antonio, Texas, 78229, United States
Minneapolis Heart Institute at Abbott Northwestern Hospital
RECRUITING

Minneapolis, Minnesota, 55407, United States
NCA Research Institute - Florida
WITHDRAWN

Naples, Florida, 34102, United States
North Central Heart
RECRUITING

Sioux Falls, South Dakota, 57108, United States
North Mississippi Medical Center
WITHDRAWN

Tupelo, Mississippi, 38801, United States
Nouvelle Clinical Research LLC
RECRUITING

Cutler Bay, Florida, 33189, United States
Nuvance Health - Danbury Hospital
RECRUITING

Danbury, Connecticut, 06810, United States
Nuvance Health - Heart & Vascular Institute/Hudson Valley Cardiovascular Practice, PC
RECRUITING

Poughkeepsie, New York, 12601, United States
Nuvance Health - Vassar brothers Medical Center
RECRUITING

Poughkeepsie, New York, 12601, United States
Ochsner Clinic Foundation
WITHDRAWN

New Orleans, Louisiana, 70121, United States
Ohio State University Wexner Medical Center
RECRUITING

Columbus, Ohio, 43210, United States
OhioHealth Research Institute
RECRUITING

Columbus, Ohio, 43214, United States
Oklahoma Heart Institute
RECRUITING

Tulsa, Oklahoma, 74104, United States
Our Lady of Lourdes
RECRUITING

Camden, New Jersey, 08103, United States
Peace Health
RECRUITING

Vancouver, Washington, 98664, United States
Penn Presbyterian Medical Center
RECRUITING

Philadelphia, Pennsylvania, 19104-6061, United States
Penn State Hershey Medical City
RECRUITING

Hershey, Pennsylvania, 17033, United States
Piedmont Healthcare
WITHDRAWN

Atlanta, Georgia, 30309, United States
Pima Heart and Vascular
RECRUITING

Tuscon, Arizona, 85712, United States
Prisma Health Upstate
RECRUITING

Greenville, South Carolina, 29601, United States
Providence Heart & Vascular
RECRUITING

Portland, Oregon, 97225, United States
Revival Clinical Research
RECRUITING

Orlando, Florida, 32807, United States
Rutgers New Jersey Medical School
WITHDRAWN

Piscataway, New Jersey, 08854, United States
Sanger Heart and Vascular
WITHDRAWN

Charlotte, North Carolina, 28203, United States
Sequoia Hospital
RECRUITING

Redwood City, California, 94062, United States
Southwest Cardiovascular Associates
RECRUITING

Mesa, Arizona, 85208, United States
St. Francis Hospital - Tulsa
RECRUITING

Tulsa, Oklahoma, 74136, United States
St. Louis Heart and Vascular
RECRUITING

Bridgeton, Missouri, 63044, United States
St. Luke's Hospital
WITHDRAWN

Chesterfield, Missouri, 63017, United States
St. Lukes Hospital Kansas City (Mid America Heart Institute)
RECRUITING

Kansas City, Missouri, 64111, United States
Swedish Medical Center
RECRUITING

Seattle, Washington, 98122, United States
Tallahassee Research Institute
WITHDRAWN

Tallahassee, Florida, 32308, United States
Temple University Hospital
RECRUITING

Philadelphia, Pennsylvania, 19140, United States
Texas Cardiac Arrhythmia Research Foundation
WITHDRAWN

Austin, Texas, 78705, United States
The Stern Cardiovascular Foundation
RECRUITING

Germantown, Tennessee, 38138, United States
Thomas Jefferson University Hospital
RECRUITING

Philadelphia, Pennsylvania, 19107, United States
Tower Health Reading Hospital
WITHDRAWN

Reading, Pennsylvania, 19611, United States
TriHealth Bethesda
WITHDRAWN

Cincinnati, Ohio, 45202, United States
Trinity health- Michigan Heart
RECRUITING

Ypsilanti, Michigan, 48197, United States
UPMC Pinnacle Harrisburg
WITHDRAWN

Harrisburg, Pennsylvania, 17110, United States
USC Keck School of Medicine
RECRUITING

Los Angeles, California, 90033, United States
University Hospitals Cleveland Medical Center
WITHDRAWN

Cleveland, Ohio, 44106, United States
University of California Davis Health
WITHDRAWN

Sacramento, California, 95817, United States
University of California San Diego
RECRUITING

La Jolla, California, 92093, United States
University of California, San Francisco
WITHDRAWN

San Francisco, California, 94143, United States
University of Iowa
RECRUITING

Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
RECRUITING

Kansas City, Kansas, 66160, United States
University of Michigan
RECRUITING

Ann Arbor, Michigan, 48113, United States
University of Nebraska Medical Center
WITHDRAWN

Omaha, Nebraska, 68198-5331, United States
University of Pittsburgh Medical Center
RECRUITING

Pittsburgh, Pennsylvania, 15213, United States
Valley Clinical Trials- Northridge
RECRUITING

Northridge, California, 91325, United States
Weill Cornell Medicine
WITHDRAWN

New York, New York, 10021, United States
WellSpan Health
WITHDRAWN

York, Pennsylvania, 17403, United States

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