This study will compare two different methods to pace the heart to treat heart failure including:
1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.
Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law
Patient meets a guideline-based indication for a de novo CRT-D device
Primary prevention indication for ICD therapy
Ischemic or nonischemic cardiomyopathy with LVEF ≤ 35% within 6 months of enrollment (LVEF must be assessed after the subject has been on GDMT for a minimum of 3 months) using an appropriate method of assessment (i.e. Echo, MRI, etc)
Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record
Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and/or other causes of expected percentage of cardiac physiologic pacing (CPP) delivery below 95% at the time of enrollment
Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment
Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment
Parallel
CRT-D with a Quadripolar LV lead
DeviceParticipants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), Quadripolar LV Lead.
CRT-D with INGEVITY+ pace/sense lead
DeviceParticipants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), INGEVITY+ pace/sense Lead (implanted in the LBBA)
Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring device therapy or external defibrillation/cardioversion.
The primary effectiveness endpoint is a composite of reduction in all-cause mortality, heart transplant, left ventricular assist device (LVAD), time to first heart failure (HF) events, time to first ventricular tachycardia (VT) / ventricular fibrillation (VF) requiring device therapy or external defibrillation/cardioversion.
System-related complication-free rate
The primary safety endpoint is System-related complication-free rate of LBBAP at 12 months. This will be a single-arm analysis of the LBBAP group compared to a performance goal
Win ratio composite assessment
Win Ratio Ranking: 1) Death 2) Heart Transplant/LVAD 3) Number of Heart Failure (HF) events (includes in-patient, out-patient and HF re-admission 4) Number of VT/VF episodes requiring device therapy or external defibrillation/cardioversion (one episode per 24 hours 5) Change in MLHFQ (Minnesota Living with Heart Failure Questionnaire) quality of life
Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ ventricular fibrillation requiring device therapy or external defibrillation/cardioversion.
The primary effectiveness endpoint is a composite of reduction in all-cause mortality, heart transplant, left ventricular assist device (LVAD), time to first heart failure (HF) events, time to first ventricular tachycardia (VT) / ventricular fibrillation (VF) requiring device therapy or external defibrillation/cardioversion.
System-related complication-free rate between randomized arms
System-related complication-free rate of LBBAP at 12 months. This will compare the two randomized arms.
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