RecruitingNot ApplicableNCT07069738

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

Sponsor

Boston Scientific Corporation

Enrollment

850 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure - NYHA II - IV

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two types of heart device implant procedures for people with heart failure and a specific electrical conduction problem in the heart: the new technique called left bundle branch area pacing (LBBAP) versus the standard cardiac resynchronization therapy (CRT), to see which better improves heart function and symptoms. **You may be eligible if...** - You are 18 or older with heart failure classified as NYHA class II–IV despite being on maximum tolerated standard medications - Your heart's pumping function (ejection fraction) is 35% or below - You have a specific heart electrical pattern called left bundle branch block (LBBB) - You have not previously had a pacemaker, defibrillator, or CRT device - You are in normal sinus heart rhythm (not atrial fibrillation) **You may NOT be eligible if...** - You have persistent or permanent atrial fibrillation - You have previously had a pacemaker, defibrillator, or CRT device - You have had a tricuspid valve replacement - You have had a recent heart attack, bypass surgery, or coronary procedure within 3 months - You have had a heart transplant or a ventricular assist device - You are pregnant or on dialysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECRT-D with a Quadripolar LV lead

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

DEVICECRT-D with INGEVITY+ pace/sense lead

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)

Locations(23)

Heart Center Research, LLC

Huntsville, Alabama, United States

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

Scripps Memorial Hospital

La Jolla, California, United States

Alta Bates Summit Medical Center

Oakland, California, United States

Cardiology Associates Medical Group, Inc.

Ventura, California, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Midwest Cardiovascular Institute

Naperville, Illinois, United States

Community Heart and Vascular Hospital

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Baptist Hospital East Louisville

Louisville, Kentucky, United States

Southcoast Physicians Group

Fall River, Massachusetts, United States

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota, United States

Centracare Heart and Vascular Center

Saint Cloud, Minnesota, United States

New York Hospital Queens

Flushing, New York, United States

Weill Cornell Medical University

New York, New York, United States

Rochester General Hospital

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota, United States

St.Thomas Health

Nashville, Tennessee, United States

Heart Hospital Baylor Plano

Plano, Texas, United States

Christus Trinity Mother Frances Health System

Tyler, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07069738

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