NCT07526896

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
38mo left

Started Aug 2026

Typical duration for not_applicable heart-failure

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

2.9 years

First QC Date

March 31, 2026

Last Update Submit

April 23, 2026

Conditions

Heart FailureSystolic Bundle Branch Block, Left

Outcome Measures

Primary Outcomes (2)

  • Left ventricular ejection fraction (LVEF)

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

    Baseline, 6 months, 12 months

  • 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).

    Baseline, 6 months, 12 months

Secondary Outcomes (2)

  • Left ventricular ejection fraction (LVEF)

    Baseline, 6 months

  • Change in LVESV at 6 Months

    Baseline, 6 months

Study Arms (2)

Sequence 1

EXPERIMENTAL

LBBAP therapy for 6 months followed by LOT-CRT for 6 months

Device: LBBAP TherapyDevice: LOT-CRT

Sequence 2

EXPERIMENTAL

LOT-CRT for 6 months followed by LBBAP therapy for 6 months

Device: LBBAP TherapyDevice: LOT-CRT

Interventions

LBBAP TherapyDEVICE

CRT-D programmed for LBBAP (LV lead OFF)

Sequence 1Sequence 2
LOT-CRTDEVICE

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

Sequence 1Sequence 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

D'Anne Kudlik

CONTACT

763-526-1843danne.e.kudlik@medtronic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 14, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

April 28, 2026

Record last verified: 2026-04