Actively Recruiting
Left vs Left Randomized Clinical Trial
Led by Baylor College of Medicine · Updated on 2025-10-02
2136
Participants Needed
71
Research Sites
302 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Left vs Left Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Left ventricular ejection fraction of 50% or less within 6 months prior to enrollment
- Resting QRS duration of 130 milliseconds or more on a 12-lead ECG before enrollment OR anticipated right ventricular pacing over 40% OR device in place with right ventricular pacing over 40%
- Optimized on heart failure guideline-directed medical therapy or patient's physician will attempt to start and adjust therapy as allowed by clinical status and co-morbidities before implantation
You will not qualify if you...
- Women who are pregnant, breastfeeding, or plan to become pregnant during the trial
- Participants with coronary disease needing revascularization likely within 3 months
- Myocardial infarction within 3 months before enrollment
- Coronary artery bypass or percutaneous coronary intervention within 3 months before enrollment
- Reversible non-ischemic cardiomyopathy such as acute viral myocarditis
- Participants with Chagas disease, cardiac sarcoidosis, or amyloidosis
- Expected to receive left ventricular assist device or heart transplant within 6 months
- Participants with severe primary valvular disease like aortic stenosis
- Life expectancy less than 12 months
- Participants with irreversible brain damage from preexisting cerebral disease
- Participants allergic to contrast dye unable to receive pretreatment
- Participants in other interventional cardiovascular clinical trials
- Participants unable to comply with follow-up schedule
- Participants with prior unsuccessful attempts at implantation of biventricular pacing, His bundle pacing, or left bundle branch pacing devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 71 locations
1
Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ
Gilbert, Arizona, United States, 85297
Actively Recruiting
2
University of Arizona College of Medicine- Phoenix
Tucson, Arizona, United States, 85719
Actively Recruiting
3
University of Arkansas for Medical Sciences (UAMS)
Little Rock, Arkansas, United States, 72205
Actively Recruiting
4
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
5
University of Colorado (Anschutz Medical Campus)
Denver, Colorado, United States, 80217
Actively Recruiting
6
South Denver Cardiology Associates
Littleton, Colorado, United States, 80124
Actively Recruiting
7
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
8
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
9
Heart Rhythm Solutions
Davie, Florida, United States, 33328
Actively Recruiting
10
University of Florida Jacksonville
Jacksonville, Florida, United States, 32211
Not Yet Recruiting
11
Mount Sinai Medical Center of Florida, Inc.
Miami Beach, Florida, United States, 33140
Not Yet Recruiting
12
Cleveland Clinic Florida
Palm Beach Gardens, Florida, United States, 33418
Actively Recruiting
13
Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC
South Pasadena, Florida, United States, 33707
Not Yet Recruiting
14
University of South Florida
Tampa, Florida, United States, 33613
Actively Recruiting
15
Rush University
Chicago, Illinois, United States, 60612
Actively Recruiting
16
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
17
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
18
CIS Clinical Research Corporation
Naperville, Illinois, United States, 60540
Enrolling by Invitation
19
Trustees of Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
20
Baptist Health Louisville
Louisville, Kentucky, United States, 40207
Actively Recruiting
21
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
22
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
23
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
24
HMH Hospitals Corporation
Hackensack, New Jersey, United States, 07601
Actively Recruiting
25
Virtua Health
Marlton, New Jersey, United States, 08053
Actively Recruiting
26
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
Actively Recruiting
27
The Valley Hospital, Inc.
Ridgewood, New Jersey, United States, 07450
Actively Recruiting
28
Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
29
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
30
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
31
Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)
New York, New York, United States, 10032
Not Yet Recruiting
32
MH Mission Hospital LLLP- Asheville Cardiology Associates
Asheville, North Carolina, United States, 28803
Actively Recruiting
33
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
34
Novant Health
Charlotte, North Carolina, United States, 28204
Actively Recruiting
35
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
36
The MetroHealth System
Cleveland, Ohio, United States, 44109
Actively Recruiting
37
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
38
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
39
St. Luke's University Health Network
Allentown, Pennsylvania, United States, 18015
Actively Recruiting
40
Lehigh Valley Hospital Inc.
Allentown, Pennsylvania, United States, 18103
Actively Recruiting
41
Penn Medicine Lancaster General
Lancaster, Pennsylvania, United States, 17603
Actively Recruiting
42
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
43
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
44
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
Actively Recruiting
45
University of Pittsburg
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
46
Geisinger Commonwealth School of Medicine
Scranton, Pennsylvania, United States, 18510
Actively Recruiting
47
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
48
Prisma Health-Upstate
Greenville, South Carolina, United States, 29605
Not Yet Recruiting
49
Texas Health Research & Education Institute
Arlington, Texas, United States, 76011
Not Yet Recruiting
50
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
51
St. Mark's Hospital
Salt Lake City, Utah, United States, 84124
Actively Recruiting
52
University of Vermont
Burlington, Vermont, United States, 05402
Actively Recruiting
53
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
54
Inova Heart and Vascular Institute
Falls Church, Virginia, United States, 22042
Actively Recruiting
55
Sentara Healthcare
Newport News, Virginia, United States, 23606
Actively Recruiting
56
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Actively Recruiting
57
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
58
Mazankowski Alberta Heart Institute/University of Alberta
Edmonton, Alberta, Canada
Not Yet Recruiting
59
University of British Columbia
Vancouver, British Columbia, Canada
Actively Recruiting
60
Victoria Cardiac Arrhythmia Trials (VCAT) Inc.
Victoria, British Columbia, Canada
Actively Recruiting
61
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Actively Recruiting
62
Hamilton Health Sciences (HHS)
Hamilton, Ontario, Canada
Actively Recruiting
63
Newmarket Electrophysiology Research Group Inc. (NERG)
Newmarket, Ontario, Canada
Actively Recruiting
64
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Actively Recruiting
65
Sunnybrook Research Institute
Toronto, Ontario, Canada
Actively Recruiting
66
Montreal Heart Institute
Montreal, Quebec, Canada
Actively Recruiting
67
CIUSSS de l'Estrie - CHUS
Saint-Jean-sur-Richelieu, Quebec, Canada
Not Yet Recruiting
68
University of Calgary
Calgary, Canada
Actively Recruiting
69
Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital
Kitchener, Canada
Actively Recruiting
70
Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital
Montreal, Canada
Actively Recruiting
71
Université Laval
Québec, Canada
Actively Recruiting
Research Team
M
Mihail G Chelu, MD, PhD
CONTACT
M
Merin Thomas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here