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

Exclusion Criteria

• •1. Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record
• •2. 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
• •3. Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment
• •4. Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment
• •5. Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers)
• •6. Prior or planned mechanical or bioprosthetic tricuspid valve replacement
• •7. Currently receiving or previously received positive inotrope therapy within 3 months prior to enrollment
• •8. Unstable angina, acute myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months prior to enrollment
• •9. History of heart transplantation or left ventricular assist device (LVAD) implantation
• •10. Less than 1 year of life expectancy at the time of enrollment
• •11. Anticipated heart transplantation or LVAD implantation within 1 year of enrollment
• •12. History of ventricular septal defect (VSD)
• •13. Complex congenital heart disease
• •14. Documented diagnosis of cardiac amyloidosis
• •15. Known occlusion or other reason limiting central venous access for transvenous leads
• •16. Women of childbearing potential who are, or plan to become, pregnant during the course of the study (assessment per investigator's discretion)
• •17. Patient currently requiring dialysis
• •18. Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
• •19. Patient with contrast dye allergy or unwilling/able to undergo pre-treatment with steroids and/or diphenhydramine
• •20. Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome
• •21. Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC.