INTEGRA-D: 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
Brief description of study
The
OPTIMIZER® INTEGRA CCM-D System, also known as a “Cardiac Contractility
Modulation – Defibrillator” is an investigational device system that combines
CCM® therapy and ICD therapy into one device. CCM therapy has been shown to
improve heart failure symptoms. This clinical trial is designed to determine if
the OPTIMIZER® INTEGRA CCM-D System can effectively defibrillate and treat
episodes of ventricular tachycardia and/or ventricular fibrillation (VT/VF),
should any occur. It also aims to improve heart failure symptoms.
Detailed description of study
During the screening period, the study team will perform
tests and assessments to make sure patients are eligible to participate in the
study. All eligible participants will receive the CCM-D system, which includes:
• an implantable pulse generator
(IPG) that generates the CCM® signals and
• Two electric wires (leads) that
will connect your heart to the IPG and deliver the CCM® therapy and, if needed,
the ICD therapy as well (see Image 1 below).
The device includes a small battery pack placed under the
skin in the upper chest just below the collar bone and one or two leads placed
through a vein into the heart. Both of the leads are programmed to deliver 5
one-hour periods of CCM® therapy every 24 hours.
Participation in the study will last up to 2 years and
involves follow-up site visits at 2 weeks and 1-month post-implant. Device
checks will occur per the standard follow-up schedule for anyone with this type
of device at 6 month intervals until reaching the 2-year post-implant point.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Heart Failure, Reduced Ejection Fraction
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Confirmed heart failure diagnosis
- Willing to give informed consent, available for study follow-up visits, and able to complete all testing
- Non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred
- Receiving guideline-directed medical therapy for heart failure
Exclusion Criteria:
- Patients who have undergone mitral valve repair or clip within 90 days prior to study consent
- Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent)
- Pregnant or planning to become pregnant during the study
- End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer)
- Prior heart transplant or ventricular assist device
- Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent
Updated on
09 Mar 2024.
Study ID: 2023-31
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