Clinical Research Directory
Browse clinical research sites, groups, and studies.
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Summary
This 2x2 randomized crossover feasibility study will evaluate the therapeutic value of adding pacing from the left ventricular lead to Left Bundle Branch Area Pacing (LBBAP) using a cardiac resynchronization therapy defibrillator (CRT-D). This combined therapy is known as Left Bundle Branch Optimized Cardiac Resynchronization Therapy (LOT-CRT) and will be compared to LBBAP therapy over sequential 6-month periods in CRT-indicated patients with LBBB. Primary and secondary outcomes are echocardiographic changes. Exploratory assessments will include NT-proBNP and subject-reported quality of life (KCCQ).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-08
Completion Date
2029-09
Last Updated
2026-04-28
Healthy Volunteers
No
Interventions
LBBAP Therapy
CRT-D programmed for LBBAP (LV lead OFF)
LOT-CRT
CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)