Assessment of Combined CCM and ICD Device in HFrEF

Launched by IMPULSE DYNAMICS · May 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the OPTIMIZER® Integra CCM-D System, which aims to help people with heart failure who continue to have symptoms despite being on standard heart failure medications. The device is designed to safely treat serious heart rhythm problems, specifically ventricular tachycardia and ventricular fibrillation, in patients who have a specific type of heart failure known as heart failure with reduced ejection fraction (HFrEF). Eligible participants for this trial are adults aged 18 and older who are experiencing significant heart failure symptoms, have a left ventricular ejection fraction of 40% or less, and have been on recommended treatments for heart failure.

If you qualify and decide to participate, you will have the device implanted, and some participants will have controlled heart rhythm issues induced in a safe environment during the procedure. You will be monitored for at least two years to evaluate how well the device works and to check for any complications. It’s important to note that certain medical conditions or recent procedures may prevent you from participating, so it’s essential to discuss your health history with the study team. This trial is currently recruiting participants, and your involvement could contribute valuable information to help improve treatment options for others with similar heart issues.

Gender

ALL

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.