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

Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Study ID
NCT07526896
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LBBAP Therapy — DEVICE
    CRT-D programmed for LBBAP (LV lead OFF)
  • LOT-CRT — DEVICE
    CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)
  • ICD — DEVICE
    ICD programmed for LBBAP
  • LOT-CRT — DEVICE
    CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)

Study Details

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). An observational treatment arm will include subjects who have not been randomized due to unsuccessful implant for real-world observational analysis

Key Dates

First listed
Apr 14, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Sequence 1
    LBBAP therapy for 6 months followed by LOT-CRT for 6 months
  • Experimental: Sequence 2
    LOT-CRT for 6 months followed by LBBAP therapy for 6 months
  • Experimental: Observational Treatment Arm

Primary Outcome Measure

Left ventricular ejection fraction (LVEF) [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts

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