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

NCT07526896 — Not applicable, Recruiting, 110 participants, Medtronic Cardiac Rhythm and Heart Failure

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RegistryNCT07526896, acronym ACHIEVED LBBAP
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: double, treatment
Enrollment110 (Estimated)
SponsorMedtronic Cardiac Rhythm and Heart Failure (Industry)
ConditionsHeart Failure, Systolic Bundle Branch Block, Left
InterventionsLBBAP Therapy, LOT-CRT, ICD (Device)
Datesstart 2026-10-13, primary completion 2029-07-01 (estimated), completion 2029-09-01 (estimated), first posted 2026-04-14, last updated 2026-10-20
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Heart Failure All trials for Systolic Bundle Branch Block, Left All trials of LBBAP Therapy All trials of LOT-CRT

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

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+Arms and interventions

ArmTypeInterventionsDescription
Sequence 1ExperimentalDevice: LBBAP Therapy; Device: LOT-CRTLBBAP therapy for 6 months followed by LOT-CRT for 6 months
Sequence 2ExperimentalDevice: LBBAP Therapy; Device: LOT-CRTLOT-CRT for 6 months followed by LBBAP therapy for 6 months
Observational Treatment ArmExperimentalDevice: ICD; Device: LOT-CRT
  • 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)

+Outcome measures

Primary outcomes

  • Left ventricular ejection fraction (LVEF) [Baseline, 6 months, 12 months]: Change in LVEF assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).
  • Left ventricular end-systolic volume (LVESV) [Baseline, 6 months, 12 months]: Change in LVESV assessed by echocardiography during each therapy period (baseline to 6 months, 6 months to 12 months).

Secondary outcomes

  • Left ventricular ejection fraction (LVEF) [Baseline, 6 months]: Change in LVEF assessed by echocardiography from baseline to 6 months
  • Left ventricular end-systolic volume (LVESV) [Baseline, 6 months]: Change in LVESV assessed by echocardiography from baseline to 6 months.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Minneapolis Heart Institute FoundationMinneapolis, MinnesotaUnited StatesRecruiting