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

NCT07069738 | Recruiting DMC FDA Device

• 1 other identifier: C2403
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 29

Brief Summary

This study will compare two different methods to pace the heart to treat heart failure including:

1. 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. 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.

Conditions

Heart Failure - NYHA II - IV

Keywords

Heart Failure; Conduction System Pacing; Primary Prevention; Cardiac Resynchronization Therapy; Left Bundle Branch Area Pacing

Outcome Measures

Primary Outcomes (2)

• Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ventricular fibrillation requiring device therapy or external defibrillation/cardioversion.

  The primary effectiveness endpoint is a composite of reduction in all-cause mortality, heart transplant, left ventricular assist device (LVAD), time to first heart failure (HF) events, time to first ventricular tachycardia (VT) / ventricular fibrillation (VF) requiring device therapy or external defibrillation/cardioversion.

  Through study completion, up to maximum of 5 years

• System-related complication-free rate

  The primary safety endpoint is System-related complication-free rate of LBBAP at 12 months. This will be a single-arm analysis of the LBBAP group compared to a performance goal

  12 months

Secondary Outcomes (3)

• Win ratio composite assessment

  Through study completion, up to a maximum of 5 years

• Composite of reduction in all-cause mortality, heart transplant, left ventricular assist device, heart failure events, ventricular tachycardia/ ventricular fibrillation requiring device therapy or external defibrillation/cardioversion.

  Through study completion, up to a maximum of 5 years

• System-related complication-free rate between randomized arms

  12 months

Study Arms (2)

CRT Cohort

ACTIVE COMPARATOR

Participants will be randomized, implanted with a BSC CRT-D device using a Quadripolar lead, and device programmed to the respective cohort.

Device: CRT-D with a Quadripolar LV lead

LBBA Cohort

EXPERIMENTAL

Participants will be randomized, implanted with a BSC CRT-D using the INGEVITY+ pace/sense lead implanted in the LBBA, and device programmed to the respective cohort.

Device: CRT-D with INGEVITY+ pace/sense lead

Interventions

CRT-D with a Quadripolar LV lead DEVICE

Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), Quadripolar LV Lead.

CRT Cohort

CRT-D with INGEVITY+ pace/sense lead DEVICE

Participants randomized to this cohort will receive a BSC system: CRT-D, Right Atrial Lead (RA), Defibrillation Lead (RV), INGEVITY+ pace/sense Lead (implanted in the LBBA)

LBBA Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (29)

Heart Center Research, LLC

Huntsville, Alabama, 35801, United States

RECRUITING

Mobile Infirmary Medical Center

Mobile, Alabama, 36608, United States

RECRUITING

Arrhythmia Research Group

Jonesboro, Arkansas, 72401, United States

RECRUITING

Scripps Memorial Hospital

La Jolla, California, 92037, United States

RECRUITING

Alta Bates Summit Medical Center

Oakland, California, 94609, United States

RECRUITING

Pacific Heart Institute

Santa Monica, California, 90404, United States

RECRUITING

Torrance Medical Center

Torrance, California, 90505, United States

RECRUITING

Cardiology Associates Medical Group, Inc.

Ventura, California, 93003, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago

Hinsdale, Illinois, 60521, United States

RECRUITING

Midwest Cardiovascular Institute

Naperville, Illinois, 60540, United States

RECRUITING

Community Heart and Vascular Hospital

Indianapolis, Indiana, 46250, United States

RECRUITING

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

Baptist Hospital East Louisville

Louisville, Kentucky, 40207, United States

RECRUITING

Southcoast Physicians Group

Fall River, Massachusetts, 02720, United States

RECRUITING

Corewell Health

Grand Rapids, Michigan, 49525, United States

RECRUITING

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota, 55805, United States

RECRUITING

Centracare Heart and Vascular Center

Saint Cloud, Minnesota, 56303, United States

RECRUITING

New York Hospital Queens

Flushing, New York, 11355, United States

RECRUITING

Weill Cornell Medical University

New York, New York, 10021, United States

RECRUITING

Rochester General Hospital

New York, New York, 14621, United States

RECRUITING

SUNY-Upstate Medical University

Syracuse, New York, 13057, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

RECRUITING

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota, 57108, United States

RECRUITING

St.Thomas Health

Nashville, Tennessee, 37205, United States

RECRUITING

Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

RECRUITING

Christus Trinity Mother Frances Health System

Tyler, Texas, 75701, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jacqueline Beaulieu

CONTACT

1-800-227-3422; jacqueline.beaulieu@bsci.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 17, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (29)