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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Systolic Bundle Branch Block, Left
• Intervention / Treatment: Device: LBBAP Therapy; Device: LOT-CRT

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: D'Anne Kudlik; Phone Number: 763-526-1843; Email: danne.e.kudlik@medtronic.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular ejection fraction (LVEF)	Change in LVEF assessed by echocardiography from baseline to 6 months	Baseline, 6 months
Change in LVESV at 6 Months	Change in LVESV assessed by echocardiography from baseline to 6 months.	Baseline, 6 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

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): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• 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