Assessment of Combined CCM and ICD Device in HFrEF

NCT05855135 | Active Not Recruiting DMC FDA Device

• 1 other identifier: RG_PRO_345
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 59

Brief 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 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.

Conditions

Heart Failure With Reduced Ejection Fraction; Heart Failure; Implantable Defibrillator User; CCM Therapy; Non-ischemic Cardiomyopathy; Ischemic Cardiomyopathy; Sudden Cardiac Arrest; Arrhythmias, Cardiac; Ventricular Tachycardia; Ventricular Fibrillation

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

Outcome Measures

Primary Outcomes (2)

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

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

  Implant

• Device-related Complications (Primary Safety Objective)

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

  Implant to 6 months

Secondary Outcomes (1)

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

  Implant to 6 months

Other Outcomes (9)

• Inappropriate Shock Rate out to 2-years

  Implant to 2 years

• Charging non-compliance

  Implant to 2 years

• Longitudinal levels of activity

  Implant to 2 years

Study Arms (1)

CCM-D Implant

EXPERIMENTAL

The subject is implanted with the CCM-D device.

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

Interventions

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.

CCM-D Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Impulse Dynamics: lead

Study Sites (59)

Phoenix Heart

Glendale, Arizona, 85306, United States

Location

CardioVascular Associates of Mesa

Mesa, Arizona, 85206, United States

Location

Southwest Cardiovascular Associates

Mesa, Arizona, 85208, United States

Location

Arizona Heart Rhythm

Phoenix, Arizona, 85016, United States

Location

CVC Cardiovascular Consultants

Phoenix, Arizona, 85032, United States

Location

Phoenix Heart

Phoenix, Arizona, 85306, United States

Location

Honor Health

Scottsdale, Arizona, 85258, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Aurora Denver Cardiology Associates

Aurora, Colorado, 80012, United States

Location

Hartford HealthCare

Hartford, Connecticut, 06102, United States

Location

Broward Health Medical Center

Fort Lauderdale, Florida, 33316, United States

Location

Baptist Health South Florida

Miami, Florida, 33173, United States

Location

Mount Sinai Medical Center Miami Beach

Miami Beach, Florida, 33140, United States

Location

Advent Health Orlando

Orlando, Florida, 32803, United States

Location

Cleveland Clinic Weston

Weston, Florida, 33331, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

St. Louis VA

St Louis, Missouri, 63106, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Virtua

Cherry Hill, New Jersey, 08034, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

The Heart House - Cardiovascular Associates of the Delaware Valley

Haddon Heights, New Jersey, 08035, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

NYU Langone

New York, New York, 10016, United States

Location

Mount Sinai New York

New York, New York, 10029, United States

Location

Columbia University Medical Center / NewYork-Presbyterian

New York, New York, 10032, United States

Location

Weill Cornell Medicine

New York, New York, 10065, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28277, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

St. Francis Tulsa

Tulsa, Oklahoma, 74136, United States

Location

Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

St. Luke's Bethlehem

Bethlehem, Pennsylvania, 18015, United States

Location

Bryn Mawr Medical Specialists Association

Bryn Mawr, Pennsylvania, 19010, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Penn Presbyterian

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15219, United States

Location

Prisma Health

Greenville, South Carolina, 29601, United States

Location

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Medical City Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Medical City Fort Worth

Fort Worth, Texas, 76104, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Houston VA Hospital

Houston, Texas, 77030, United States

Location

Christus Trinity Clinic

Tyler, Texas, 75702, United States

Location

Centra Health

Lynchburg, Virginia, 24501, United States

Location

Chippenham Hospital

Richmond, Virginia, 23225, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Seattle VA

Seattle, Washington, 98108, United States

Location

Swedish

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Heart Failure; Death, Sudden, Cardiac; Arrhythmias, Cardiac; Tachycardia, Ventricular; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Niraj Varma, MD, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Nir Uriel, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 11, 2023
• Study Start: May 17, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (59)