Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
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
Interventions
CRT-D with a Quadripolar LV lead
CRT-D with INGEVITY+ pace/sense lead
Conditions
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