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

Inclusion criteria

• ✓. 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)
• ✓. NYHA class II-IV despite maximally tolerated guideline directed medical therapy (GDMT)\* for at least 3 months
• ✓. Sinus rhythm with left bundle branch block (LBBB) defined as a QRS ≥ 140 ms in men and ≥ 130 ms in women with a predominantly negative deflection (QS or rS in lead V1 and mid QRS notching or slurring in at least two of the following leads: 1, aVL, V1, V2, V5, V6) within 3 months of enrollment
• ✓. Patient is willing to participate in LATITUDE™ NXT remote patient monitoring
• ✓. Patient is willing and capable of providing informed consent and participating in all testing associated with this investigation at an approved study site and at the protocol defined intervals (Note: Use of a legally authorized representative (LAR) is not allowed)