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

August 17, 2026 updated by: Medtronic Cardiac Rhythm and Heart Failure
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence 1
LBBAP therapy for 6 months followed by LOT-CRT for 6 months
Device: LBBAP Therapy
CRT-D programmed for LBBAP (LV lead OFF)
Device: LOT-CRT
CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)
Experimental: Sequence 2
LOT-CRT for 6 months followed by LBBAP therapy for 6 months
Device: LBBAP Therapy
CRT-D programmed for LBBAP (LV lead OFF)
Device: LOT-CRT
CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)
Experimental: Observational Treatment Arm
Device: LOT-CRT
CRT-D programmed for LOT-CRT (LBBAP + LV lead ON)
Device: ICD
ICD programmed for LBBAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction (LVEF)
Time Frame: Baseline, 6 months, 12 months
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)
Time Frame: Baseline, 6 months, 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction (LVEF)
Time Frame: Baseline, 6 months
Change in LVEF assessed by echocardiography from baseline to 6 months
Baseline, 6 months
Left ventricular end-systolic volume (LVESV)
Time Frame: Baseline, 6 months
Change in LVESV assessed by echocardiography from baseline to 6 months.
Baseline, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

September 1, 2029

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT25031

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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