No phaseRecruiting
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure (SYNCHRONICITY)
- Sponsor
- Boston Scientific Corporation (Industry)
- Enrolment
- 850 planned
- Conditions
- Heart Failure - NYHA II - IV
- Interventions
- CRT-D with a Quadripolar LV lead; CRT-D with INGEVITY+ pace/sense lead
- Ages
- adults, older adults
- Registry
- NCT07069738
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- 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.
- System-related complication-free rate
History
Primary completion expected
Last registry update
Started
Registered