Back to Trials
NCT07069738NARecruiting

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

Boston Scientific Corporation

Start Date

10/22/2025

Completion Date

11/1/2029

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

CRT-D with a Quadripolar LV lead

DEVICE

CRT-D with INGEVITY+ pace/sense lead

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Heart Failure - NYHA II - IV

Locations

Heart Center Research, LLC

Huntsville, Alabama 35801

United States

Mobile Infirmary Medical Center

Mobile, Alabama 36608

United States

Arrhythmia Research Group

Jonesboro, Arkansas 72401

United States

Scripps Memorial Hospital

La Jolla, California 92037

United States

Cedars Sinai Medical Center

Las Angeles, California 90048

United States

Alta Bates Summit Medical Center

Oakland, California 94609

United States

Pacific Heart Institute

Santa Monica, California 90404

United States

Torrance Medical Center

Torrance, California 90505

United States

Cardiology Associates Medical Group, Inc.

Ventura, California 93003

United States

Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

Sarasota Memorial Hospital

Sarasota, Florida 34239

United States

AdventHealth Tampa

Tampa, Florida 33613

United States

Emory University Hospital

Altanta, Georgia 30322

United States

University of Chicago

Hinsdale, Illinois 60521

United States

Midwest Cardiovascular Institute

Naperville, Illinois 60540

United States

Community Heart and Vascular Hospital

Indianapolis, Indiana 46250

United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa 52242

United States

Baptist Hospital East Louisville

Louisville, Kentucky 40207

United States

Southcoast Physicians Group

Fall River, Massachusetts 02720

United States

Corewell Health

Grand Rapids, Michigan 49525

United States

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota 55805

United States

Centracare Heart and Vascular Center

Saint Cloud, Minnesota 56303

United States

Morristown Medical Center

Morristown, New Jersey 07932

United States

New York Hospital Queens

Flushing, New York 11355

United States

Weill Cornell Medical University

New York, New York 10021

United States

Rochester General Hospital

New York, New York 14621

United States

SUNY-Upstate Medical University

Syracuse, New York 13057

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

Columbus, Ohio 43214

United States

Mount Carmel Health System

Columbus, Ohio 43219

United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania 19104

United States

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota 57108

United States

St.Thomas Health

Nashville, Tennessee 37205

United States

Heart Hospital Baylor Plano

Plano, Texas 75093

United States

Christus Trinity Mother Frances Health System

Tyler, Texas 75701

United States