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New heart device aims to stop deadly rhythms in heart failure patients

NCT ID NCT05855135

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study tests a new device that combines two heart therapies: one to strengthen heartbeats and another to stop dangerous rhythms. About 300 adults with heart failure and a weak heart pump will get the device. Researchers will check if it safely converts life-threatening heart rhythms and reduces unnecessary shocks over two years.

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 300 people

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

Started

May 2023

Expected to finish

Jul 2027

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: Individuals must meet all the following: 1. Patient is aged 18 years or older; 2. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ; 3. Patient has HFrEF (LVEF ≤40%); 4. Patient is on GDMT for heart failure; 5. Patient has a Class I or Class II indication for an ICD 6. Patient has a reasonable expectation of meaningful survival of \> 1 year; 7. Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred; 8. Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR; 2. Patients who have undergone mitral valve repair or clip within 90 days prior to study consent; 3. Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent; 4. Prior heart transplant or ventricular assist device; 5. Implanted mechanical tricuspid valve; 6. PR interval greater than 375ms or advanced AV block; 7. In situ S-ICD, pacemaker, or CRT device; 8. Indicated for CRT; 9. End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer); 10. Indicated for permanent bradyarrhythmia pacing; 11. Unstable angina pectoris within 30 days prior to study consent; 12. Pregnant or planning to become pregnant during the study; 13. Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable. 14. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac cardiac rhythm disease cardiomyopathy cerebral cavernous malformation Death, Sudden, Cardiac heart failure sudden cardiac arrest systolic heart failure ventricular fibrillation ventricular tachycardia

As listed by the trial registrant

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

Arrhythmias, cardiac CCM therapy Heart failure Heart failure with reduced ejection fraction Implantable defibrillator user Ischemic cardiomyopathy Non-ischemic cardiomyopathy Sudden cardiac arrest Ventricular fibrillation Ventricular tachycardia

Contacts and locations

Locations

  • Advent Health Orlando

    Orlando, Florida, 32803, United States

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212, United States

  • Arizona Heart Rhythm

    Phoenix, Arizona, 85016, United States

  • Baptist Health Lexington

    Lexington, Kentucky, 40503, United States

  • Baptist Health South Florida

    Miami, Florida, 33173, United States

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316, United States

  • Bryn Mawr Medical Specialists Association

    Bryn Mawr, Pennsylvania, 19010, United States

  • CVC Cardiovascular Consultants

    Phoenix, Arizona, 85032, United States

  • CardioVascular Associates of Mesa

    Mesa, Arizona, 85206, United States

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Centra Health

    Lynchburg, Virginia, 24501, United States

  • Chippenham Hospital

    Richmond, Virginia, 23225, United States

  • Christus Trinity Clinic

    Tyler, Texas, 75702, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Columbia University Medical Center / NewYork-Presbyterian

    New York, New York, 10032, United States

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hartford HealthCare

    Hartford, Connecticut, 06102, United States

  • Honor Health

    Scottsdale, Arizona, 85258, United States

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Houston VA Hospital

    Houston, Texas, 77030, United States

  • Iowa Heart Center

    West Des Moines, Iowa, 50266, United States

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602, United States

  • Louis Stokes Cleveland VA Medical Center

    Cleveland, Ohio, 44106, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical City Dallas

    Dallas, Texas, 75230, United States

  • Medical City Fort Worth

    Fort Worth, Texas, 76104, United States

  • Mount Sinai Medical Center Miami Beach

    Miami Beach, Florida, 33140, United States

  • Mount Sinai New York

    New York, New York, 10029, United States

  • NYU Langone

    New York, New York, 10016, United States

  • Penn Presbyterian

    Philadelphia, Pennsylvania, 19104, United States

  • Phoenix Heart

    Glendale, Arizona, 85306, United States

  • Phoenix Heart

    Phoenix, Arizona, 85306, United States

  • Portland VA Medical Center

    Portland, Oregon, 97239, United States

  • Prisma Health

    Greenville, South Carolina, 29601, United States

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111, United States

  • Sanger Heart and Vascular Institute

    Charlotte, North Carolina, 28277, United States

  • Seattle VA

    Seattle, Washington, 98108, United States

  • Southwest Cardiovascular Associates

    Mesa, Arizona, 85208, United States

  • St. Francis Tulsa

    Tulsa, Oklahoma, 74136, United States

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136, United States

  • St. Louis VA

    St Louis, Missouri, 63106, United States

  • St. Luke's Bethlehem

    Bethlehem, Pennsylvania, 18015, United States

  • Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138, United States

  • Swedish

    Seattle, Washington, 98122, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705, United States

  • The Heart House - Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey, 08035, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • UT Memorial Hermann

    Houston, Texas, 77030, United States

  • UT Southwestern

    Dallas, Texas, 75390, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66103, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15219, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Virtua

    Cherry Hill, New Jersey, 08034, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.