Assessment of Combined CCM and ICD Device in HFrEF (INTEGRA-D)
Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring 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
Eligibility Criteria
Inclusion Criteria: Individuals must meet all the following: Patient is aged 18 years or older; Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ; Patient has HFrEF (LVEF ≤40%); Patient is on GDMT for heart failure; Patient has a Class I or Class II indication for an ICD Patient has a reasonable expectation of meaningful survival of > 1 year; Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred; 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: Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR; Patients who have undergone mitral valve repair or clip within 90 days prior to study consent; Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent; Prior heart transplant or ventricular assist device; Implanted mechanical tricuspid valve; PR interval greater than 375ms or advanced AV block; In situ S-ICD, pacemaker, or CRT device; Indicated for CRT; End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer); Indicated for permanent bradyarrhythmia pacing; Unstable angina pectoris within 30 days prior to study consent; Pregnant or planning to become pregnant during the study; 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. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.
Sites / Locations
- CardioVascular Associates of MesaRecruiting
- Chan Heart Rhythm InstituteRecruiting
- CVC Cardiovascular ConsultantsRecruiting
- Honor HealthRecruiting
- Baptist Health South FloridaRecruiting
- Advent Health OrlandoRecruiting
- University of Kansas Medical CenterRecruiting
- Massachusetts General HospitalRecruiting
- VirtuaRecruiting
- Cleveland ClinicRecruiting
- The Ohio State University Wexner Medical CenterRecruiting
- Lancaster General HospitalRecruiting
- Temple UniversityRecruiting
- Allegheny General HospitalRecruiting
- Christus Trinity ClinicRecruiting
Arms of the Study
Arm 1
Experimental
CCM-D Implant
The subject is implanted with the CCM-D device.