RECRUITING
I'm interested ...!!
Assessment of Combined CCM and ICD Device in HFrEF
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 🦠 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
More conditions available...
🗓️ Study Start (Actual) 17 May 2023
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 300
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Mesa, Arizona, United States
📍 Mesa, Arizona, United States
📍 Phoenix, Arizona, United States
📍 Scottsdale, Arizona, United States
📍 Los Angeles, California, United States
📍 Aurora, Colorado, United States
📍 Hartford, Connecticut, United States
📍 Fort Lauderdale, Florida, United States
📍 Miami Beach, Florida, United States
📍 Miami, Florida, United States
📍 Orlando, Florida, United States
📍 Kansas City, Kansas, United States
📍 Lexington, Kentucky, United States
📍 Boston, Massachusetts, United States
📍 Kansas City, Missouri, United States
📍 Kansas City, Missouri, United States
📍 Cherry Hill, New Jersey, United States
📍 Haddon Heights, New Jersey, United States
📍 Newark, New Jersey, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Cleveland, Ohio, United States
📍 Columbus, Ohio, United States
📍 Bethlehem, Pennsylvania, United States
📍 Bryn Mawr, Pennsylvania, United States
📍 Lancaster, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Philadelphia, Pennsylvania, United States
📍 Pittsburgh, Pennsylvania, United States
📍 Austin, Texas, United States
📍 Dallas, Texas, United States
📍 Dallas, Texas, United States
📍 Fort Worth, Texas, United States
📍 Houston, Texas, United States
📍 Tyler, Texas, United States
📍 Lynchburg, Virginia, United States
📍 Richmond, Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 May 2023
  • First Submitted that Met QC Criteria 3 May 2023
  • First Posted 11 May 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 9 July 2024
  • Last Update Posted 11 July 2024
  • Last Verified July 2024
I'm interested ...!!