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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
850
Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), Quadripolar LV Lead.
Participants 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)
Heart Center Research, LLC
Huntsville, Alabama, United States
RECRUITINGMobile Infirmary Medical Center
Mobile, Alabama, United States
RECRUITINGArrhythmia Research Group
Jonesboro, Arkansas, United States
RECRUITINGAlta Bates Summit Medical Center
Oakland, California, United States
RECRUITINGCardiology Associates Medical Group, Inc.
Ventura, California, United States
RECRUITINGSarasota Memorial Hospital
Sarasota, Florida, United States
RECRUITINGMidwest Cardiovascular Institute
Naperville, Illinois, United States
RECRUITINGCentracare Heart and Vascular Center
Saint Cloud, Minnesota, United States
RECRUITINGNew York Hospital Queens
Flushing, New York, United States
RECRUITINGWeill Cornell Medical University
New York, New York, United States
RECRUITING...and 2 more locations
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.
Time frame: Through study completion, up to maximum of 5 years
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
Time frame: 12 months
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
Time frame: Through study completion, up to a maximum of 5 years
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.
Time frame: Through study completion, up to a maximum of 5 years
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.
Time frame: 12 months
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