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Heart FailureINTEGRA-DNCT05855135

Assessment of Combined CCM and ICD Device in HFrEF

A study testing OPTIMIZER® Integra CCM-D System (Treatment Arm) in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Impulse Dynamics at 59 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
OPTIMIZER® Integra CCM-D System (Treatment Arm)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
59 sitesUnited States
Study dates
17 May 2023to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Individuals must meet all the following:
  • Patient is aged 18 years or older;
  • Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
  • Patient has HFrEF (LVEF ≤40%);
  • Patient is on GDMT for heart failure;
  • Patient has a Class I or Class II indication for an ICD
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  • Patient has a reasonable expectation of meaningful survival of > 1 year;
  • Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
  • 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.

Who cannot join

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
  • Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
  • Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
  • Prior heart transplant or ventricular assist device;
  • Implanted mechanical tricuspid valve;
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  • PR interval greater than 375ms or advanced AV block;
  • In situ S-ICD, pacemaker, or CRT device;
  • Indicated for CRT;
  • End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
  • Indicated for permanent bradyarrhythmia pacing;
  • Unstable angina pectoris within 30 days prior to study consent;
  • Pregnant or planning to become pregnant during the study;
  • 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.
  • Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.

Trial locations and contacts

59 sites in 1 country.

59 sites in 1 country

United States59 sites

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • St. Luke's Bethlehem

    Bethlehem, Pennsylvania, 18015

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Bryn Mawr Medical Specialists Association

    Bryn Mawr, Pennsylvania, 19010

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Sanger Heart and Vascular Institute

    Charlotte, North Carolina, 28277

  • Virtua

    Cherry Hill, New Jersey, 08034

  • Louis Stokes Cleveland VA Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Medical City Dallas

    Dallas, Texas, 75230

  • UT Southwestern

    Dallas, Texas, 75390

  • Broward Health Medical Center

    Fort Lauderdale, Florida, 33316

  • Medical City Fort Worth

    Fort Worth, Texas, 76104

  • Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138

  • Phoenix Heart

    Glendale, Arizona, 85306

  • Prisma Health

    Greenville, South Carolina, 29601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The Heart House - Cardiovascular Associates of the Delaware Valley

    Haddon Heights, New Jersey, 08035

  • Hartford HealthCare

    Hartford, Connecticut, 06102

  • Houston Methodist

    Houston, Texas, 77030

  • Houston VA Hospital

    Houston, Texas, 77030

  • UT Memorial Hermann

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66103

  • Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Centra Health

    Lynchburg, Virginia, 24501

  • CardioVascular Associates of Mesa

    Mesa, Arizona, 85206

  • Southwest Cardiovascular Associates

    Mesa, Arizona, 85208

  • Baptist Health South Florida

    Miami, Florida, 33173

  • Mount Sinai Medical Center Miami Beach

    Miami Beach, Florida, 33140

  • NYU Langone

    New York, New York, 10016

  • Mount Sinai New York

    New York, New York, 10029

  • Columbia University Medical Center / NewYork-Presbyterian

    New York, New York, 10032

  • Weill Cornell Medicine

    New York, New York, 10065

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Advent Health Orlando

    Orlando, Florida, 32803

  • Penn Presbyterian

    Philadelphia, Pennsylvania, 19104

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Arizona Heart Rhythm

    Phoenix, Arizona, 85016

  • CVC Cardiovascular Consultants

    Phoenix, Arizona, 85032

  • Phoenix Heart

    Phoenix, Arizona, 85306

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15219

  • Portland VA Medical Center

    Portland, Oregon, 97239

  • Chippenham Hospital

    Richmond, Virginia, 23225

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Honor Health

    Scottsdale, Arizona, 85258

  • Seattle VA

    Seattle, Washington, 98108

  • Swedish

    Seattle, Washington, 98122

  • St. Louis VA

    St Louis, Missouri, 63106

  • St. Louis Heart and Vascular

    St Louis, Missouri, 63136

  • St. Francis Tulsa

    Tulsa, Oklahoma, 74136

  • Christus Trinity Clinic

    Tyler, Texas, 75702

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

Other trials in United States

About this study

Official title: Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects With Heart Failure and Reduced Ejection Fraction

The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%).

Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.

Being tested
OPTIMIZER® Integra CCM-D System (Treatment Arm)
Keywords
Heart Failure, HFrEF, Stage C Heart Failure, Stage D Heart Failure, Defibrillation Efficacy Testing, Induced Ventricular Fibrillation, Ventricular fibrillation, Ventricular tachycardia, Implantable cardioverter defibrillator, Sudden cardiac arrest
Medical subject headings
Heart Failure, Death, Sudden, Cardiac, Arrhythmias, Cardiac, Tachycardia, Ventricular, Ventricular Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OPTIMIZER® Integra CCM-D System (Treatment Arm)Device

    The CCM-D System is an implantable cardiac device system that combines cardiac contractility modulation and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a "Cardiac Contractility Modulation - Defibrillator". All 300 subjects will be implanted with the CCM-D System and followed for a period of at least two years.

Study groups in NCT05855135
Study groupRoleWhat they receive
CCM-D ImplantExperimentalThe subject is implanted with the CCM-D device.
Receives: Device: OPTIMIZER® Integra CCM-D System (Treatment Arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)

    Evaluate the device effectiveness in converting induced VF at the time of implantation.

    Measured: Implant

  2. Device-related Complications (Primary Safety Objective)

    Evaluate device-related complications through 6-months (excluding lead-related complications).

    Measured: Implant to 6 months

Secondary outcomes (1)

  1. Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)

    Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit.

    Measured: Implant to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2023
  2. Study start17 May 2023
  3. Primary completion31 Dec 2025
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm, prospective, multicenter study of 300 subjects that will establish that the device can appropriately sense and convert episodes of induced VF "on the table" in the implant procedure room, spontaneous episodes of VT/VF that occur during the study follow-up period, and ensure that the inappropriate shock rate is not unacceptably high.
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05855135
Sponsor's protocol ID
RG_PRO_345
Acronym
INTEGRA-D
Status last verified
Nov 2026
First submitted
3 May 2023
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing OPTIMIZER® Integra CCM-D System (Treatment Arm) in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Impulse Dynamics at 59 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective) (time frame: Implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05855135.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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