Recruiting

LOT-CRT & LBBAP

Sponsor:

Medtronic Cardiac Rhythm and Heart Failure

Code:

NCT07526896

Conditions

Heart Failure

Systolic Bundle Branch Block, Left

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LBBAP Therapy

LOT-CRT

ICD

LOT-CRT

Study Details

Brief 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

Conditions

Heart Failure

Systolic Bundle Branch Block, Left

Study ID

NCT07526896

Start date

Oct 13, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Jul, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

LBBAP Therapy

CRT-D programmed for LBBAP (LV lead OFF)

LOT-CRT

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

ICD

ICD programmed for LBBAP

LOT-CRT

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Robert Stadler

763-526-0261robert.stadler@medtronic.com

Locations

Minneapolis Heart Institute Foundation

Recruiting

Minneapolis, Minnesota, United States, 55407

Principal Investigator:

John Zakaib

More Information

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Last update posted

Oct 20, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Medtronic Cardiac Rhythm and Heart Failure on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.