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Not yet recruiting NCT07526896

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

No phase Interventional Heart Failure Systolic Bundle Branch Block, Left

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LBBAP Therapy, LOT-CRT, ICD, LOT-CRT.
Who it may be relevant to
Registry conditions: Heart Failure, Systolic Bundle Branch Block, Left. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • Left ventricular ejection fraction (LVEF) [Time frame: Baseline, 6 months, 12 months]
  • Left ventricular end-systolic volume (LVESV) [Time frame: Baseline, 6 months, 12 months]
Secondary outcome measures (2)
  • Left ventricular ejection fraction (LVEF) [Time frame: Baseline, 6 months]
  • Left ventricular end-systolic volume (LVESV) [Time frame: Baseline, 6 months]

Eligibility criteria

Inclusion criteria

  • 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.
  • Subject is willing and able to provide written consent.
  • Subject is at least 18 years of age at the time of consent.
  • Subject is geographically stable and willing and able to complete study procedures, including follow-up visits.
  • The subject's medical records must be accessible by the enrolling site over the follow-up period.

Exclusion criteria

  • 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).
  • Subject has intrinsic (non-paced) QRS duration ≤ 120ms.
  • Subject with previous or existing pacemaker (including transvenous and transcatheter pacing system), Implantable Cardioverter Defibrillator (ICD, transvenous) or CRT-D (transvenous) device or leads.
  • Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve).
  • Subject underwent valve surgery within 90 days prior to enrollment.
  • Subject is unable or unwilling to undergo baseline CMR imaging, if previously collected CMR images are unavailable or do not meet minimum acceptable criteria.
  • Subject is post-heart transplantation or is actively listed on the transplantation list.
  • Subject is implanted with a left ventricular assist device (LVAD).
  • Subject has severe renal disease.
  • Subject is on continuous or uninterrupted infusion (inotropic) therapy for heart failure.
  • Subject has complex and uncorrected congenital heart disease.
  • Subject has life expectancy of less than 12 months.
  • Subject is pregnant or breastfeeding.
  • Subject is enrolled or planning to enroll in a concurrent clinical study that may confound the results of this study, without documented pre-approval from a Medtronic study manager.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07526896 · MDT25031

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗