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Left bundle branch area pacing versus conventional cardiac resynchronization therapy for heart failure

Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure

Not applicable Interventional Boston Scientific Corporation · NCT07069738

This study will test whether left bundle branch area pacing (LBBAP) works as well as or better than conventional cardiac resynchronization therapy (CRT) in adults with NYHA II–IV heart failure and reduced ejection fraction who are receiving a CRT‑D device.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment850 (estimated)
Ages18 Years and up
SexAll
SponsorBoston Scientific Corporation Industry-sponsored
Locations29 sites (Huntsville, Alabama and 28 other locations)
Trial IDNCT07069738 on ClinicalTrials.gov

What this trial studies

Adults with symptomatic heart failure (NYHA II–IV) and LVEF ≤35% after at least 3 months on guideline‑directed medical therapy will be enrolled if they have a guideline-based indication for a de novo CRT‑D. Participants will receive either a conventional CRT system with a quadripolar left‑ventricular lead or a CRT‑D system using a left bundle branch area pacing (LBBAP) lead, implanted at participating centers. The LBBAP lead is FDA‑approved for implantation in that location but not specifically labeled for heart failure therapy; the trial will track safety, pacing effectiveness, device performance, and clinical measures of heart function and symptoms. Follow‑up visits and device checks will monitor complications and functional outcomes over the study period.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with ischemic or nonischemic cardiomyopathy, LVEF ≤35% after ≥3 months on guideline‑directed medical therapy, NYHA class II–IV symptoms, and a guideline-based indication for a de novo CRT‑D for primary prevention.

Not a fit: Patients with LVEF >35%, NYHA class I symptoms, those who are not candidates for CRT‑D implantation, or who cannot tolerate guideline medical therapy are unlikely to benefit from this comparison.

Why it matters

Potential benefit: If successful, LBBAP could offer a more physiological pacing option that improves heart function or symptoms and potentially reduces lead-related complications compared with conventional CRT.

How similar studies have performed: Smaller observational and nonrandomized studies of conduction system pacing (including His‑bundle and LBBAP) have shown promising improvements in electrical synchrony and some clinical markers, but randomized head‑to‑head evidence versus conventional CRT remains limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law
2. Patient meets a guideline-based indication for a de novo CRT-D device
3. Primary prevention indication for ICD therapy
4. Ischemic or nonischemic cardiomyopathy with LVEF ≤ 35% within 6 months of enrollment (LVEF must be assessed after the subject has been on GDMT for a minimum of 3 months) using an appropriate method of assessment (i.e. Echo, MRI, etc)
5. NYHA class II-IV despite maximally tolerated guideline directed medical therapy (GDMT)\* for at least 3 months

   \*GDMT is defined as all four drug classes listed below for at least 3 months prior to enrollment unless the investigator provides justification (e.g., contraindicated, not tolerated or cost): Renin Angiotensin System Inhibitors (ACE, ARB, or ARNI) Evidence based betablockers (metoprolol succinate, carvedilol, bisoprolol) Mineralocorticoid antagonists SGLT2 Inhibitor medications
6. Sinus rhythm with left bundle branch block (LBBB) defined as a QRS ≥ 140 ms in men and ≥ 130 ms in women with a predominantly negative deflection (QS or rS in lead V1 and mid QRS notching or slurring in at least two of the following leads: 1, aVL, V1, V2, V5, V6) within 3 months of enrollment
7. Patient is willing to participate in LATITUDE™ NXT remote patient monitoring
8. Patient is willing and capable of providing informed consent and participating in all testing associated with this investigation at an approved study site and at the protocol defined intervals (Note: Use of a legally authorized representative (LAR) is not allowed)
9. Patient plans to remain geographically stable (not permanently moving to another location) and can commit to all study participation requirements (procedure, follow-up visits and testing requirements)

Exclusion Criteria:

1. Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record
2. Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and/or other causes of expected percentage of cardiac physiologic pacing (CPP) delivery below 95% at the time of enrollment
3. Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment
4. Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment
5. Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers)
6. Prior or planned mechanical or bioprosthetic tricuspid valve replacement
7. Currently receiving or previously received positive inotrope therapy within 3 months prior to enrollment
8. Unstable angina, acute myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months prior to enrollment
9. History of heart transplantation or left ventricular assist device (LVAD) implantation
10. Less than 1 year of life expectancy at the time of enrollment
11. Anticipated heart transplantation or LVAD implantation within 1 year of enrollment
12. History of ventricular septal defect (VSD)
13. Complex congenital heart disease
14. Documented diagnosis of cardiac amyloidosis
15. Known occlusion or other reason limiting central venous access for transvenous leads
16. Women of childbearing potential who are, or plan to become, pregnant during the course of the study (assessment per investigator's discretion)
17. Patient currently requiring dialysis
18. Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
19. Patient with contrast dye allergy or unwilling/able to undergo pre-treatment with steroids and/or diphenhydramine
20. Inability or refusal to comply with the follow-up schedule including subject living at such a distance from the investigational site that attending follow-up visits would be unusually difficult or burdensome
21. Patient is enrolled in any other concurrent study. Co-enrollment into other studies such as observational studies/registries needs prior written approval by BSC. Local mandatory governmental registries are accepted for co-enrollment without approval by BSC.

Where this trial is running

Huntsville, Alabama and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure - NYHA II - IVHeart FailureConduction System PacingPrimary PreventionCardiac Resynchronization TherapyLeft Bundle Branch Area Pacing
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.