Evolving Indications, Challenges and Advances in Cardiac Resynchronization Therapy for Heart Failure.
Temidayo A Abe, Endurance O Evbayekha, Larry R Jackson...
https://pubmed.ncbi.nlm.nih.gov/40250827Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05650658
Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing With a Left Ventricular Epicardial Lead in Patients With Heart Failure and Reduced Ejection Fraction (LVEF ≤50%) and Wide QRS or High Pacing Needs Randomized Clinical Trial
Led by Baylor College of Medicine · Updated on 2025-10-02
2136
Participants Needed
71
Research Sites
N/A
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
This research aims to compare two pacing methods, His or Left bundle branch pacing (His/LBBP) and biventricular pacing (BiVP), in patients with heart failure caused by left ventricular systolic dysfunction (LVEF ≤50%) who have either a wide QRS duration (≥130 ms) or require/anticipate more than 40% pacing. The study focuses on patient-centered outcomes such as quality of life, physical activity, hospitalizations for heart failure, mortality, and device-related complications like lead dislodgement and infection, while participants continue standard heart failure medication. Participants are randomly assigned to receive either His/LBBP or BiVP devices. For patients with LVEF ≤35%, the His/LBBP group receives a defibrillator with three implanted leads, including a His-bundle or left bundle branch pacing lead, while those with LVEF 36-50% receive a pacemaker with two leads. The BiVP group receives a defibrillator with three leads for LVEF ≤35% and a pacemaker with three leads, including an epicardial left ventricular lead, for LVEF 36-50%. The pacing devices aim to synchronize heartbeats through different approaches to improve heart function. Throughout the study, participants are monitored for up to 5.5 years. Researchers will assess combined outcomes of all-cause death and heart failure hospitalizations as the primary measure. Secondary assessments include quality of life changes, psychological adjustment at one year, and heart function measured by left ventricular volume changes. Patient activity and heart failure symptoms will also be tracked using questionnaires, walk tests, and implanted device data. Safety and complications related to the devices will be closely followed during the study period.
CONDITIONS
Brief Title
Left vs Left Randomized Clinical Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older
- Left ventricular ejection fraction (LVEF) of 50% or less within 6 months prior to enrollment
- Resting QRS duration of 130 milliseconds or more OR anticipated or existing right ventricular pacing greater than 40%
- Optimized on heart failure guideline-directed medical therapy or planned initiation and dose adjustment as allowed by clinical status
You will not qualify if you...
- Women who are pregnant, lactating, or plan to become pregnant during the trial
- Candidates for coronary revascularization likely to undergo surgery or intervention within 3 months
- Myocardial infarction within 3 months prior to enrollment
- Coronary artery bypass graft or percutaneous coronary intervention within 3 months prior to enrollment
- Reversible non-ischemic cardiomyopathy such as acute viral myocarditis
- Presence of Chagas disease, cardiac sarcoidosis, or amyloidosis
- Expected heart transplant or left ventricular assist device within 6 months
- Severe primary valvular disease like aortic stenosis
- Life expectancy less than 12 months
- Irreversible brain damage from existing cerebral disease
- Contrast dye allergy without pre-treatment willingness
- Participation in other interventional cardiovascular clinical trials
- Inability to comply with follow-up visits
- Prior unsuccessful attempts at implantation of biventricular, His bundle, or left bundle branch pacing devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Day of procedure and immediate recovery period
Participants undergo implantation of a device for cardiac resynchronization therapy either using His/Left Bundle Branch Pacing or Biventricular Pacing with a left ventricular epicardial lead.
1 visit (in-person) for device implantation
Post-operative Follow-up
Duration - Up to 5.5 years
Participants are followed after device implantation to monitor recovery and device function.
Regular follow-up visits as scheduled by the study team
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
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Research Team
M
Mihail G Chelu, MD, PhD
M
Merin Thomas
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Physiological Pacing for the Prevention and Treatment of Heart Failure: a State-of-the-Art Review.
Margaret Infeld, Jamie A Cyr, Damián Sánchez-Quintana...
https://pubmed.ncbi.nlm.nih.gov/39481799