Left vs Left Randomized Clinical Trial
Recruiting · NCT05650658 · Interventional (participants receive a specific treatment) · Lead sponsor: Baylor College of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
BiVPHis/LBBP
What this trial is about
The investigators aim to prospectively test the comparative effectiveness of His or Left bundle branch pacing in relation to patient centered outcomes (quality of life, physical activity, heart failure hospitalization, mortality) and comparative safety in relation to device-related complications and re-interventions (e.g., lead dislodgement, infection) relative to standard of care biventricular pacing in patients with heart failure due to left ventricular systolic dysfunction (LVEF≤50%) and with either a wide QRS (≥130 ms) or with/anticipated \>40% pacing who are already receiving current standard heart failure pharmacological therapy.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Men and women 18 years of age or older.
- A LVEF ≤ 50% within 6 months prior to enrollment.
- Resting QRS duration ≥130 ms as evidenced by a historical 12-lead ECG prior to enrollment OR anticipated right ventricular pacing \>40% OR device in place with right ventricular pacing \> 40%.
- Are optimized on HF guideline directed medical therapy according to current HF published guidelines OR patient's physician will make an effort to start all guideline-directed medical therapy and titrate doses up as permitted by the participant clinical status and co-morbidities prior to implantation procedure.
Exclusion criteria
- Women who are pregnant, lactating, or plan to become pregnant during the course of the trial.
- Participants with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary, intervention in the next three (3) months.
- Enzyme-positive myocardial infarction within the past three (3) months prior to enrollment.
- Coronary artery bypass graft surgery or percutaneous coronary intervention (balloon and/or stent angioplasty) within the past three (3) months prior to enrollment.
- Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).
- Participants with Chagas disease, cardiac sarcoidosis or amyloidosis.
- Expected to receive left ventricular assist device or heart transplantation within 6 months.
- Participants with primary severe valvular disease (e.g., aortic stenosis).
- Have a life expectancy of less than 12 months.
- Participants with irreversible brain damage from preexisting cerebral disease.
- Participants with a contrast dye allergy unable or unwilling to undergo pretreatment with steroids and/or diphenhydramine.
- Participants participating in any other interventional cardiovascular clinical trial.
- Participants who would be unable to comply with the study's follow-up visit schedule; or
- Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device.
Where it is running
60 locations listed across 24 US states.
- Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ - Gilbert, Arizona, United States
- University of Arizona College of Medicine- Phoenix - Tucson, Arizona, United States
- University of Arkansas for Medical Sciences (UAMS) - Little Rock, Arkansas, United States
- University of California San Diego - La Jolla, California, United States
- University of Colorado (Anschutz Medical Campus) - Denver, Colorado, United States
- South Denver Cardiology Associates - Littleton, Colorado, United States
- Hartford Hospital - Hartford, Connecticut, United States
- Yale University - New Haven, Connecticut, United States
- Heart Rhythm Solutions - Davie, Florida, United States
- University of Florida Jacksonville - Jacksonville, Florida, United States
- Mount Sinai Medical Center of Florida, Inc. - Miami Beach, Florida, United States
- Cleveland Clinic Florida - Palm Beach Gardens, Florida, United States
- Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC - South Pasadena, Florida, United States
- University of South Florida - Tampa, Florida, United States
- Rush University - Chicago, Illinois, United States
- University of Chicago - Chicago, Illinois, United States
- Northwestern University - Evanston, Illinois, United States
- CIS Clinical Research Corporation - Naperville, Illinois, United States
- Trustees of Indiana University - Indianapolis, Indiana, United States
- Baptist Health Louisville - Louisville, Kentucky, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center - Boston, Massachusetts, United States
- Mayo Clinic - Rochester, Minnesota, United States
- HMH Hospitals Corporation - Hackensack, New Jersey, United States
- Virtua Health - Marlton, New Jersey, United States
- Newark Beth Israel Medical Center - Newark, New Jersey, United States
- The Valley Hospital, Inc. - Ridgewood, New Jersey, United States
- Lovelace Medical Center - Albuquerque, New Mexico, United States
- Weill Cornell Medicine - New York, New York, United States
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH) - New York, New York, United States
- MH Mission Hospital LLLP- Asheville Cardiology Associates - Asheville, North Carolina, United States
- University of North Carolina - Chapel Hill, North Carolina, United States
- Novant Health - Charlotte, North Carolina, United States
- The Christ Hospital - Cincinnati, Ohio, United States
- The MetroHealth System - Cleveland, Ohio, United States
- Cleveland Clinic - Cleveland, Ohio, United States
- Oregon Health & Science University - Portland, Oregon, United States
- St. Luke's University Health Network - Allentown, Pennsylvania, United States
- Lehigh Valley Hospital Inc. - Allentown, Pennsylvania, United States
- Penn Medicine Lancaster General - Lancaster, Pennsylvania, United States
- University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Thomas Jefferson University Hospital - Philadelphia, Pennsylvania, United States
- Allegheny-Singer Research Institute - Pittsburgh, Pennsylvania, United States
- University of Pittsburg - Pittsburgh, Pennsylvania, United States
- Geisinger Commonwealth School of Medicine - Scranton, Pennsylvania, United States
- Medical University of South Carolina (MUSC) - Charleston, South Carolina, United States
- Prisma Health-Upstate - Greenville, South Carolina, United States
- Texas Health Research & Education Institute - Arlington, Texas, United States
- Baylor College of Medicine - Houston, Texas, United States
- St. Mark's Hospital - Salt Lake City, Utah, United States
- University of Vermont - Burlington, Vermont, United States
- University of Virginia Health System - Charlottesville, Virginia, United States
- Inova Heart and Vascular Institute - Falls Church, Virginia, United States
- Sentara Healthcare - Newport News, Virginia, United States
- Virginia Commonwealth University - Richmond, Virginia, United States
- University of Washington - Seattle, Washington, United States
- University of Calgary - Calgary, Canada
- Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital - Kitchener, Canada
- Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital - Montreal, Canada
Showing 60 of 71 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →