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Two Heart Pacing Approaches for Heart Failure With Left Bundle Branch Block

Compares two pacing therapies in adults with heart failure and left bundle branch block.

Key facts

Who runs it
Medtronic Cardiac Rhythm and Heart Failure
Where
Minneapolis, United StatesSee the site
Trial code
Registry title
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
Status
Recruiting
People taking part
110 people, planned
Started
13 Oct 2026
Expected to end
Sept 2029
Type of study
Interventional, 3 groups
Treatments tested
  • LBBAP Therapy
  • LOT-CRT
  • ICD
Record updated
20 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with heart failure and a left bundle branch block who need a cardiac resynchronization device (CRT-D). It compares two ways of pacing the heart.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Heart failure with LVEF of 35% or less within 60 days before enrollment, NYHA class II or III, and left bundle branch block (Strauss-defined). The person meets current ACC/AHA/HRS guidelines for a CRT-D device.
Earlier treatment
No earlier pacemaker, ICD or CRT-D device or leads. No valve surgery within 90 days before enrollment. No heart transplant, and not on a transplant list.
Biomarker or test result
Intrinsic (non-paced) QRS duration longer than 120ms is needed, since 120ms or less excludes a person.

Main reasons for not taking part

  • Earlier heart attack (myocardial infarction)
  • Right bundle branch block or other non-LBBB conduction patterns
  • 2nd or 3rd degree AV block
  • Persistent or permanent atrial fibrillation or atrial flutter
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 25 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 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 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
  • Subject has documented myocardial infarction before enrollment
  • Subject has contraindications for screw-in transvenous lead placement (e.g., mechanical right heart valve)
  • Subject is post-heart transplantation or is actively listed on the transplantation list
  • 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 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 is implanted with a left ventricular assist device (LVAD)
  • Subject has life expectancy of less than 12 months
  • Subject is pregnant or breastfeeding

Where in United States

  • Minneapolis Heart Institute FoundationMinneapolis, United StatesContact: Ellen ThomasTaking people

About the trial

What the trial wants to find out

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

The 3 groups in the trial

  • Sequence 1Treatment being tested

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

    Treatment: LBBAP Therapy and LOT-CRT

  • Sequence 2Treatment being tested

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

    Treatment: LBBAP Therapy and LOT-CRT

  • Observational Treatment ArmTreatment being tested

    Treatment: ICD and LOT-CRT

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Advancing Clinical Heart Failure Outcomes Leveraging Defibrillation Lead Implant System for Left Bundle Branch Area Pacing
Plain-language title
Two Heart Pacing Approaches for Heart Failure With Left Bundle Branch BlockGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
20 October 2026