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

ConditionsHeart FailureSystolic Bundle Branch Block, Left
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedtronic Cardiac Rhythm and Heart Failure

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject meets current ACC/AHA/HRS guidelines for implantation of a CRT-D device.

Subject has documented LVEF ≤ 35% within 60 days of enrollment.

Subject meets the criteria for presence of Strauss-defined LBBB.

Subject meets NYHA classification II or III.

Disqualifiers

Subject has documented myocardial infarction before enrollment.

Subject has non-LBBB conduction patterns such as Right Bundle Branch Block (RBBB) or non-specific IVCD.

Subject has 2nd or 3rd degree AV block.

Subject has persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL).

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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)

Treatment groups

110 Participants
are divided into 3 treatment groups
Group A: Sequence 1Experimental treatment 2 interventions
Group B: Sequence 2Experimental treatment 2 interventions
Group C: Observational Treatment ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Left ventricular ejection fraction (LVEF)

Change in LVEF assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).

Time frame
Baseline, 6 months, 12 months
2

Left ventricular end-systolic volume (LVESV)

Change in LVESV assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).

Time frame
Baseline, 6 months, 12 months

Secondary outcomes

1

Left ventricular ejection fraction (LVEF)

Change in LVEF assessed by echocardiography from baseline to 6 months

Time frame
Baseline, 6 months
2

Left ventricular end-systolic volume (LVESV)

Change in LVESV assessed by echocardiography from baseline to 6 months.

Time frame
Baseline, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medtronic Cardiac Rhythm and Heart Failure

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: