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

Recruiting now · Not applicable

Conditions studied: Heart Failure - NYHA II - IV

In brief

This study will compare two different methods to pace the heart to treat heart failure including: 1. The current standard method of implanting a pacing lead in a vein on the surface of the left lower chamber of the heart (left ventricle) to deliver heart failure therapy. This method is called Cardiac Resynchronization Therapy (CRT). 2. The other method is using a lead implanted in the Left Bundle Branch Area (LBBA) of your heart. This method is called Left Bundle Branch Area Pacing or LBBAP. This lead is approved by the Food and Drug Administration (FDA) to be implanted in this area of the heart, but not to provide heart failure treatment.

Key facts

Study ID: NCT07069738
Run by: Boston Scientific Corporation
People needed: 850
Starts: 2025-10-22
Expected to finish: 2029-11-01
Last updated by the study team: 2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patient is age 18 years or above, or of legal age to give informed consent specific to state and national law
Patient meets a guideline-based indication for a de novo CRT-D device
Primary prevention indication for ICD therapy
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)
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
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
Patient is willing to participate in LATITUDE™ NXT remote patient monitoring
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)
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)

You may not qualify if…

Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollment and documented in the medical record
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
Non-LBBB conduction abnormalities (including right bundle branch block (RBB) or intraventricular conduction delay (IVCD)) within 3 months prior to enrollment
Complete, second degree or high degree atrioventricular (AV) block, that requires pacing at the time of enrollment
Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICD technology and leadless pacemakers)
Prior or planned mechanical or bioprosthetic tricuspid valve replacement
Currently receiving or previously received positive inotrope therapy within 3 months prior to enrollment
Unstable angina, acute myocardial infarction, coronary artery bypass grafting, or percutaneous coronary intervention within 3 months prior to enrollment
History of heart transplantation or left ventricular assist device (LVAD) implantation
Less than 1 year of life expectancy at the time of enrollment
Anticipated heart transplantation or LVAD implantation within 1 year of enrollment
History of ventricular septal defect (VSD)
Complex congenital heart disease
Documented diagnosis of cardiac amyloidosis
Known occlusion or other reason limiting central venous access for transvenous leads
Women of childbearing potential who are, or plan to become, pregnant during the course of the study (assessment per investigator's discretion)
Patient currently requiring dialysis
Patient with known or suspected sensitivity to Dexamethasone Acetate (DXA)
Patient with contrast dye allergy or unwilling/able to undergo pre-treatment with steroids and/or diphenhydramine
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
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 it is running

Heart Center Research, LLC — Huntsville, Alabama, United States (enrolling)
Mobile Infirmary Medical Center — Mobile, Alabama, United States (enrolling)
Mayo Clinic Phoenix — Phoenix, Arizona, United States (enrolling)
Arrhythmia Research Group — Jonesboro, Arkansas, United States (enrolling)
Scripps Memorial Hospital — La Jolla, California, United States (enrolling)
Cedars Sinai Medical Center — Los Angeles, California, United States (enrolling)
Alta Bates Summit Medical Center — Oakland, California, United States (enrolling)
Pacific Heart Institute — Santa Monica, California, United States (enrolling)
Torrance Medical Center — Torrance, California, United States (enrolling)
Cardiology Associates Medical Group, Inc. — Ventura, California, United States (enrolling)
Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
Sarasota Memorial Hospital — Sarasota, Florida, United States (enrolling)
AdventHealth Tampa — Tampa, Florida, United States (enrolling)
Emory University Hospital — Atlanta, Georgia, United States (enrolling)
University of Chicago — Hinsdale, Illinois, United States (enrolling)
Midwest Cardiovascular Institute — Naperville, Illinois, United States (enrolling)
Community Heart and Vascular Hospital — Indianapolis, Indiana, United States (enrolling)
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (enrolling)
Baptist Hospital East Louisville — Louisville, Kentucky, United States (enrolling)
Southcoast Physicians Group — Fall River, Massachusetts, United States (enrolling)
University of Michigan Hospitals — Ann Arbor, Michigan, United States (enrolling)
Corewell Health — Grand Rapids, Michigan, United States (enrolling)
St. Mary's Duluth Clinic Regional Heart Center — Duluth, Minnesota, United States (enrolling)
Centracare Heart and Vascular Center — Saint Cloud, Minnesota, United States (enrolling)
Morristown Medical Center — Morristown, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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