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NOT YET RECRUITING
NCT07526896
NA

Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

View on ClinicalTrials.gov

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

DEVICE

LBBAP Therapy

CRT-D programmed for LBBAP (LV lead OFF)

DEVICE

LOT-CRT

CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)