Clinical trial NCT05855135: Assessment of Combined CCM and ICD Device in HFrEF
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
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
Lead sponsor: Impulse Dynamics
Sponsor class: INDUSTRY
First posted: 2023-05-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)
timeFrame: Implant
measure: Device-related Complications (Primary Safety Objective)
timeFrame: Implant to 6 months
Secondary outcomes:
measure: Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)
timeFrame: Implant to 6 months
Other outcomes:
measure: Inappropriate Shock Rate out to 2-years
timeFrame: Implant to 2 years
measure: Charging non-compliance
timeFrame: Implant to 2 years
measure: Longitudinal levels of activity
timeFrame: Implant to 2 years
measure: Battery degradation and longevity
timeFrame: Implant to 2 years
Locations:
city: Glendale
country: United States
facility: Phoenix Heart
state: Arizona
city: Mesa
country: United States
facility: CardioVascular Associates of Mesa
state: Arizona
city: Mesa
country: United States
facility: Chan Heart Rhythm Institute
state: Arizona
city: Mesa
country: United States
facility: Southwest Cardiovascular Associates
state: Arizona
city: Phoenix
country: United States
facility: Arizona Heart Rhythm
state: Arizona
city: Phoenix
country: United States
facility: CVC Cardiovascular Consultants
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Heart
state: Arizona
city: Scottsdale
country: United States
facility: Honor Health
state: Arizona
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Aurora
country: United States
facility: Aurora Denver Cardiology Associates
state: Colorado
city: Hartford
country: United States
facility: Hartford HealthCare
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Broward Health Medical Center
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center Miami Beach
state: Florida
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Orlando
country: United States
facility: Advent Health Orlando
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Weston
state: Florida
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Baton Rouge
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Mid America Heart Institute
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis VA
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Omaha
state: Nebraska
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Cherry Hill
country: United States
facility: Virtua
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Haddon Heights
country: United States
facility: The Heart House - Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: New York
country: United States
facility: NYU Langone
state: New York
city: New York
country: United States
facility: Mount Sinai New York
state: New York
city: New York
country: United States
facility: Columbia University Medical Center / NewYork-Presbyterian
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Sanger Heart and Vascular Institute
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Tulsa
country: United States
facility: St. Francis Tulsa
state: Oklahoma
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Bethlehem
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Bryn Mawr Medical Specialists Association
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Fort Worth
country: United States
facility: Medical City Fort Worth
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: Houston VA Hospital
state: Texas
city: Tyler
country: United States
facility: Christus Trinity Clinic
state: Texas
city: Lynchburg
country: United States
facility: Centra Health
state: Virginia
city: Richmond
country: United States
facility: Chippenham Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Seattle VA
state: Washington
city: Seattle
country: United States
facility: Swedish
state: Washington
city: Milwaukee
country: United States
facility: Aurora St. Luke&#39;s Medical Center
state: Wisconsin
Study officials:
affiliation: The Cleveland Clinic
name: Niraj Varma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Nir Uriel, MD
role: PRINCIPAL_INVESTIGATOR
References: