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

Last updated: May 4, 2026
Sponsor: Boston Scientific Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Heart Failure

Chest Pain

Treatment

CRT-D with INGEVITY+ pace/sense lead

CRT-D with a Quadripolar LV lead

Clinical Study ID

NCT07069738
C2403
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  1. Patient is age 18 years or above, or of legal age to give informed consent specificto 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 priorto 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

  1. Sinus rhythm with left bundle branch block (LBBB) defined as a QRS ≥ 140 ms in menand ≥ 130 ms in women with a predominantly negative deflection (QS or rS in lead V1and mid QRS notching or slurring in at least two of the following leads: 1, aVL, V1,V2, V5, V6) within 3 months of enrollment

  2. Patient is willing to participate in LATITUDE™ NXT remote patient monitoring

  3. Patient is willing and capable of providing informed consent and participating inall testing associated with this investigation at an approved study site and at theprotocol defined intervals (Note: Use of a legally authorized representative (LAR)is not allowed)

  4. Patient plans to remain geographically stable (not permanently moving to anotherlocation) and can commit to all study participation requirements (procedure,follow-up visits and testing requirements)

Exclusion

Exclusion Criteria:

  1. Persistent or permanent atrial fibrillation (AF) within 3 months prior to enrollmentand documented in the medical record

  2. Frequent premature ventricular contractions (PVCs), atrial arrhythmias, and/or othercauses 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) orintraventricular conduction delay (IVCD)) within 3 months prior to enrollment

  4. Complete, second degree or high degree atrioventricular (AV) block, that requirespacing at the time of enrollment

  5. Current or prior pacemaker, ICD or CRT implant (Also includes non-transvenous ICDtechnology and leadless pacemakers)

  6. Prior or planned mechanical or bioprosthetic tricuspid valve replacement

  7. Currently receiving or previously received positive inotrope therapy within 3 monthsprior to enrollment

  8. Unstable angina, acute myocardial infarction, coronary artery bypass grafting, orpercutaneous 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 thecourse 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 withsteroids and/or diphenhydramine

  20. Inability or refusal to comply with the follow-up schedule including subject livingat such a distance from the investigational site that attending follow-up visitswould be unusually difficult or burdensome

  21. Patient is enrolled in any other concurrent study. Co-enrollment into other studiessuch as observational studies/registries needs prior written approval by BSC. Localmandatory governmental registries are accepted for co-enrollment without approval byBSC.

Study Design

Total Participants: 850
Treatment Group(s): 2
Primary Treatment: CRT-D with INGEVITY+ pace/sense lead
Phase:
Study Start date:
October 22, 2025
Estimated Completion Date:
November 30, 2029

Connect with a study center

  • Heart Center Research, LLC

    Huntsville, Alabama 35801
    United States

    Active - Recruiting

  • Mobile Infirmary Medical Center

    Mobile, Alabama 36608
    United States

    Active - Recruiting

  • Heart Center Research, LLC

    Huntsville 4068590, Alabama 4829764 35801
    United States

    Site Not Available

  • Mobile Infirmary Medical Center

    Mobile 4076598, Alabama 4829764 36608
    United States

    Site Not Available

  • Arrhythmia Research Group

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • Arrhythmia Research Group

    Jonesboro 4116834, Arkansas 4099753 72401
    United States

    Site Not Available

  • Scripps Memorial Hospital

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Alta Bates Summit Medical Center

    Oakland, California 94609
    United States

    Active - Recruiting

  • Pacific Heart Institute

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Torrance Medical Center

    Torrance, California 90505
    United States

    Active - Recruiting

  • Cardiology Associates Medical Group, Inc.

    Ventura, California 93003
    United States

    Active - Recruiting

  • Alta Bates Summit Medical Center

    Oakland 5378538, California 5332921 94609
    United States

    Site Not Available

  • Cardiology Associates Medical Group, Inc.

    Ventura 5405878, California 5332921 93003
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Sarasota Memorial Hospital

    Sarasota 4172131, Florida 4155751 34239
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • University of Chicago

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

  • Midwest Cardiovascular Institute

    Naperville, Illinois 60540
    United States

    Active - Recruiting

  • Midwest Cardiovascular Institute

    Naperville 4903279, Illinois 4896861 60540
    United States

    Site Not Available

  • Community Heart and Vascular Hospital

    Indianapolis, Indiana 46250
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Baptist Hospital East Louisville

    Louisville, Kentucky 40207
    United States

    Active - Recruiting

  • Southcoast Physicians Group

    Fall River, Massachusetts 02720
    United States

    Active - Recruiting

  • Corewell Health

    Grand Rapids, Michigan 49525
    United States

    Active - Recruiting

  • St. Mary's Duluth Clinic Regional Heart Center

    Duluth, Minnesota 55805
    United States

    Active - Recruiting

  • Centracare Heart and Vascular Center

    Saint Cloud, Minnesota 56303
    United States

    Active - Recruiting

  • Centracare Heart and Vascular Center

    Saint Cloud 5044407, Minnesota 5037779 56303
    United States

    Site Not Available

  • New York Hospital Queens

    Flushing, New York 11355
    United States

    Active - Recruiting

  • Rochester General Hospital

    New York, New York 14621
    United States

    Active - Recruiting

  • Weill Cornell Medical University

    New York, New York 10021
    United States

    Active - Recruiting

  • SUNY-Upstate Medical University

    Syracuse, New York 13057
    United States

    Active - Recruiting

  • New York Hospital Queens

    Flushing 5117472, New York 5128638 11355
    United States

    Site Not Available

  • Weill Cornell Medical University

    New York 5128581, New York 5128638 10021
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

    Columbus, Ohio 43214
    United States

    Active - Recruiting

  • Avera Heart Hospital of South Dakota

    Sioux Falls, South Dakota 57108
    United States

    Active - Recruiting

  • Avera Heart Hospital of South Dakota

    Sioux Falls 5231851, South Dakota 5769223 57108
    United States

    Site Not Available

  • St.Thomas Health

    Nashville, Tennessee 37205
    United States

    Active - Recruiting

  • Heart Hospital Baylor Plano

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Christus Trinity Mother Frances Health System

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • Christus Trinity Mother Frances Health System

    Tyler 4738214, Texas 4736286 75701
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.