Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston Scientific Corporation

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • CRT-D with a Quadripolar LV lead
  • CRT-D with INGEVITY+ pace/sense lead

Treatment groups

850 Participants
are divided into 2 treatment groups

Sponsors and collaborators