CCM Device for Heart Failure
(INTEGRA-D Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the OPTIMIZER® Integra CCM-D System to determine its safety and effectiveness in managing dangerous heart rhythms in individuals with advanced heart failure. The device aims to assist those with reduced heart function who continue to experience symptoms despite standard heart failure treatments. Participants should have heart failure, experience troubling heart rhythms, and not qualify for certain other heart treatments. The trial involves implanting the device and monitoring for complications over at least two years. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could lead to new treatment options for heart failure.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should already be on guideline-directed medical therapy for heart failure, so you may need to continue those medications.
What prior data suggests that the CCM-D System is safe for heart failure patients?
Research has shown that the OPTIMIZER® Integra CCM-D System has been safely implanted and tested in 100 patients. In these tests, the device effectively addressed heart rhythm issues such as ventricular fibrillation, a serious heart problem. This indicates that patients generally tolerate the device well. The FDA has also approved the CCM-D system for treating heart failure, which supports its safety. While all medical procedures carry some risks, current data suggests that this device is generally safe for treating heart failure.12345
Why are researchers excited about this trial?
Researchers are excited about the OPTIMIZER® Integra CCM-D System for heart failure because it introduces a unique approach called cardiac contractility modulation (CCM). Unlike traditional treatments like medications and devices that primarily focus on improving heart pumping efficiency or managing symptoms, the CCM-D device directly enhances the strength of heart contractions by delivering electrical signals to the heart muscle. This novel mechanism could offer a new avenue for patients who do not respond well to existing therapies, potentially improving their quality of life and heart function.
What evidence suggests that the CCM-D System is effective for heart failure?
Studies have shown that the OPTIMIZER® Integra CCM-D System works well for patients with heart failure. In a study with 100 patients, researchers successfully placed the device, and tests confirmed it effectively controlled dangerous heart rhythms. This indicates the device can help manage serious heart issues in people with heart failure. In this trial, participants will receive the CCM-D Implant, which includes cardiac contractility modulation (CCM) therapy, approved by the FDA for treating heart failure. This treatment targets patients whose hearts don't pump effectively, even when they are on regular medication.12356
Who Is on the Research Team?
Niraj Varma, MD
Principal Investigator
The Cleveland Clinic
Nir Uriel, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for adults over 18 with heart failure (HFrEF) and a left ventricular ejection fraction (LVEF) of 40% or less, who are symptomatic despite treatment but don't qualify for cardiac resynchronization therapy. They must not be pregnant, have severe valve disease, unstable angina, other major medical conditions like end-stage renal disease, or be in another device/drug study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation
Eligible subjects are implanted with the CCM-D System, and a subset is induced into ventricular fibrillation during the procedure
Initial Follow-up
Evaluate device-related complications and inappropriate ICD shocks
Long-term Follow-up
Monitor inappropriate shock rate, device effectiveness, and battery longevity
What Are the Treatments Tested in This Trial?
Interventions
- OPTIMIZER® Integra CCM-D System
OPTIMIZER® Integra CCM-D System is already approved in United States, European Union for the following indications:
- Moderate to severe chronic heart failure in patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for cardiac resynchronization therapy, and have a left ventricular ejection fraction ranging from 25 to 45 percent
- Moderate to severe chronic heart failure in patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for cardiac resynchronization therapy, and have a left ventricular ejection fraction ranging from 25 to 45 percent
Find a Clinic Near You
Who Is Running the Clinical Trial?
Impulse Dynamics
Lead Sponsor