Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07069738

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

Led by Boston Scientific Corporation · Updated on 2026-05-05

850

Participants Needed

29

Research Sites

210 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older or legal age to give informed consent
  • Meets guideline-based indication for new CRT-D device implantation
  • Eligible for primary prevention ICD therapy
  • Has ischemic or nonischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of 35% or less within 6 months
  • LVEF assessed after at least 3 months on guideline-directed medical therapy (GDMT)
  • NYHA class II to IV despite maximum tolerated GDMT for at least 3 months
  • Sinus rhythm with left bundle branch block as defined by specific ECG criteria within 3 months
  • Willing to participate in LATITUDE NXT remote patient monitoring
  • Able and willing to provide informed consent and participate in all study testing
  • Plans to remain geographically stable and commit to all study requirements
Not Eligible

You will not qualify if you...

  • Persistent or permanent atrial fibrillation within 3 months before enrollment
  • Frequent premature ventricular contractions, atrial arrhythmias, or other causes reducing cardiac physiologic pacing below 95%
  • Non-left bundle branch block conduction abnormalities within 3 months before enrollment
  • Complete, second degree, or high degree atrioventricular block requiring pacing at enrollment
  • Current or prior pacemaker, ICD, or CRT implant including non-transvenous ICDs and leadless pacemakers
  • Prior or planned mechanical or bioprosthetic tricuspid valve replacement
  • Receiving or recently received positive inotrope therapy within 3 months
  • Recent unstable angina, myocardial infarction, coronary bypass, or stent procedure within 3 months
  • History of heart transplant or left ventricular assist device (LVAD) implantation
  • Life expectancy less than 1 year at enrollment
  • Anticipated heart transplant or LVAD within 1 year
  • History of ventricular septal defect
  • Complex congenital heart disease
  • Diagnosis of cardiac amyloidosis
  • Known limited central venous access for transvenous leads
  • Women of childbearing potential who are pregnant or plan to become pregnant during the study
  • Currently requiring dialysis
  • Known sensitivity to Dexamethasone Acetate
  • Allergy to contrast dye or unable/unwilling to receive pre-treatment
  • Unable or unwilling to comply with follow-up schedule or living too far from site
  • Enrolled in any other concurrent study without prior approval

AI-Screening

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Trial Site Locations

Total: 29 locations

1

Heart Center Research, LLC

Huntsville, Alabama, United States, 35801

Actively Recruiting

2

Mobile Infirmary Medical Center

Mobile, Alabama, United States, 36608

Actively Recruiting

3

Arrhythmia Research Group

Jonesboro, Arkansas, United States, 72401

Actively Recruiting

4

Scripps Memorial Hospital

La Jolla, California, United States, 92037

Actively Recruiting

5

Alta Bates Summit Medical Center

Oakland, California, United States, 94609

Actively Recruiting

6

Pacific Heart Institute

Santa Monica, California, United States, 90404

Actively Recruiting

7

Torrance Medical Center

Torrance, California, United States, 90505

Actively Recruiting

8

Cardiology Associates Medical Group, Inc.

Ventura, California, United States, 93003

Actively Recruiting

9

Sarasota Memorial Hospital

Sarasota, Florida, United States, 34239

Actively Recruiting

10

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

11

University of Chicago

Hinsdale, Illinois, United States, 60521

Actively Recruiting

12

Midwest Cardiovascular Institute

Naperville, Illinois, United States, 60540

Actively Recruiting

13

Community Heart and Vascular Hospital

Indianapolis, Indiana, United States, 46250

Actively Recruiting

14

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States, 52242

Actively Recruiting

15

Baptist Hospital East Louisville

Louisville, Kentucky, United States, 40207

Actively Recruiting

16

Southcoast Physicians Group

Fall River, Massachusetts, United States, 02720

Actively Recruiting

17

Corewell Health

Grand Rapids, Michigan, United States, 49525

Actively Recruiting

18

St. Mary's Duluth Clinic Regional Heart Center

Duluth, Minnesota, United States, 55805

Actively Recruiting

19

Centracare Heart and Vascular Center

Saint Cloud, Minnesota, United States, 56303

Actively Recruiting

20

New York Hospital Queens

Flushing, New York, United States, 11355

Actively Recruiting

21

Weill Cornell Medical University

New York, New York, United States, 10021

Actively Recruiting

22

Rochester General Hospital

New York, New York, United States, 14621

Actively Recruiting

23

SUNY-Upstate Medical University

Syracuse, New York, United States, 13057

Actively Recruiting

24

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

25

OhioHealth Research and Innovation Institute-Riverside Methodist Hospital

Columbus, Ohio, United States, 43214

Actively Recruiting

26

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota, United States, 57108

Actively Recruiting

27

St.Thomas Health

Nashville, Tennessee, United States, 37205

Actively Recruiting

28

Heart Hospital Baylor Plano

Plano, Texas, United States, 75093

Actively Recruiting

29

Christus Trinity Mother Frances Health System

Tyler, Texas, United States, 75701

Actively Recruiting

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Research Team

J

Jacqueline Beaulieu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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