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NCT05650658Recruiting

Left vs Left Randomized Clinical Trial

Cardiac Resynchronization Therapy Using His/Left Bundle Branch Pacing vs Biventricular Pacing With a Left Ventricular Epicardial Lead in Patients With Heart Failure (HF) With Left Ventricular Ejection Fraction (LVEF)≤50% and With Either a Wide QRS Complex (>130 ms) or With/Anticipated >40% Pacing Randomized Clinical Trial

Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
2136 (estimated)
First submitted
24 Nov 2022
Start date
13 Sept 2023
Primary completion date
30 Jun 2029
Lead sponsor
Baylor College of Medicine
NCT number
NCT05650658

What you commit to

  • Study type: Interventional
  • Planned participants: 2136
  • From 13 Sept 2023 to the primary completion date, 30 Jun 2029
  • 71 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Participants who had any prior unsuccessful attempt at implantation of biventricular pacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device.

Other illness

  • 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.
  • 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).
  • 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.

Other

  • Women who are pregnant, lactating, or plan to become pregnant during the course of the trial.
  • Reversible non-ischemic cardiomyopathy (e.g., acute viral myocarditis).
  • Have a life expectancy of less than 12 months.
  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (71)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Of Calgary
Coordinator of this site? Confirm its status
CalgaryCanadaRecruiting
Mazankowski Alberta Heart Institute/University of Alberta
Coordinator of this site? Confirm its status
EdmontonCanadaNot yet recruiting
Nova Scotia Health Authority
Coordinator of this site? Confirm its status
HalifaxCanadaRecruiting
Hamilton Health Sciences (HHS)
Coordinator of this site? Confirm its status
HamiltonCanadaRecruiting
Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital
Coordinator of this site? Confirm its status
KitchenerCanadaRecruiting
Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Montreal Heart Institute
Coordinator of this site? Confirm its status
MontrealCanadaRecruiting
Newmarket Electrophysiology Research Group Inc. (NERG)
Coordinator of this site? Confirm its status
NewmarketCanadaRecruiting
University of Ottawa Heart Institute
Coordinator of this site? Confirm its status
OttawaCanadaRecruiting
Universite Laval
Coordinator of this site? Confirm its status
QuébecCanadaRecruiting
CIUSSS de l'Estrie - CHUS
Coordinator of this site? Confirm its status
Saint-Jean-sur-RichelieuCanadaNot yet recruiting
Sunnybrook Research Institute
Coordinator of this site? Confirm its status
TorontoCanadaRecruiting
University of British Columbia
Coordinator of this site? Confirm its status
VancouverCanadaRecruiting
Victoria Cardiac Arrhythmia Trials (VCAT) Inc.
Coordinator of this site? Confirm its status
VictoriaCanadaRecruiting
Lovelace Medical Center
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesRecruiting
St. Luke's University Health Network
Coordinator of this site? Confirm its status
AllentownUnited StatesRecruiting
Lehigh Valley Hospital, Inc
Coordinator of this site? Confirm its status
AllentownUnited StatesRecruiting
Texas Health Research & Education Institute
Coordinator of this site? Confirm its status
ArlingtonUnited StatesNot yet recruiting
MH Mission Hospital LLLP- Asheville Cardiology Associates
Coordinator of this site? Confirm its status
AshevilleUnited StatesRecruiting
Massachusetts General Hospital
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of Vermont
Coordinator of this site? Confirm its status
BurlingtonUnited StatesRecruiting
University of North Carolina
Coordinator of this site? Confirm its status
Chapel HillUnited StatesRecruiting
Medical University of South Carolina (MUSC)
Coordinator of this site? Confirm its status
CharlestonUnited StatesRecruiting
Novant Health
Coordinator of this site? Confirm its status
CharlotteUnited StatesRecruiting
University of Virginia Health System
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesRecruiting
RUSH University
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
The Christ Hospital
Coordinator of this site? Confirm its status
CincinnatiUnited StatesRecruiting
The MetroHealth System
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Cleveland Clinic
Coordinator of this site? Confirm its status
ClevelandUnited StatesRecruiting
Heart Rhythm Solutions
Coordinator of this site? Confirm its status
DavieUnited StatesRecruiting
University of Colorado (Anschutz Medical Campus)
Coordinator of this site? Confirm its status
DenverUnited StatesRecruiting
Northwestern University
Coordinator of this site? Confirm its status
EvanstonUnited StatesRecruiting
Inova Heart and Vascular Institute
Coordinator of this site? Confirm its status
Falls ChurchUnited StatesRecruiting
Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ
Coordinator of this site? Confirm its status
GilbertUnited StatesRecruiting
Prisma Health-Upstate
Coordinator of this site? Confirm its status
GreenvilleUnited StatesNot yet recruiting
HMH Hospitals Corporation
Coordinator of this site? Confirm its status
HackensackUnited StatesRecruiting
Hartford Hospital
Coordinator of this site? Confirm its status
HartfordUnited StatesRecruiting
Baylor College of Medicine
Coordinator of this site? Confirm its status
HoustonUnited StatesRecruiting
Trustees of Indiana University
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
University of Florida - Jacksonville
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JacksonvilleUnited StatesNot yet recruiting
University of California San Diego
Coordinator of this site? Confirm its status
La JollaUnited StatesRecruiting
Penn Medicine Lancaster General
Coordinator of this site? Confirm its status
LancasterUnited StatesRecruiting
University of Arkansas for Medical Sciences (UAMS)
Coordinator of this site? Confirm its status
Little RockUnited StatesRecruiting
South Denver Cardiology Associates
Coordinator of this site? Confirm its status
LittletonUnited StatesRecruiting
Baptist Health Louisville
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
Virtua Health
Coordinator of this site? Confirm its status
MarltonUnited StatesRecruiting
Mount Sinai Medical Center of Florida, Inc.
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Miami BeachUnited StatesNot yet recruiting
CIS Clinical Research Corporation
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NapervilleUnited StatesEnrolling by invitation
Newark Beth Israel Medical Center
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NewarkUnited StatesRecruiting
Yale University
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New HavenUnited StatesRecruiting
Sentara Healthcare
Coordinator of this site? Confirm its status
Newport NewsUnited StatesRecruiting
Weill Cornell Medicine
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New YorkUnited StatesRecruiting
Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)
Coordinator of this site? Confirm its status
New YorkUnited StatesNot yet recruiting
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Cleveland Clinic Florida
Coordinator of this site? Confirm its status
Palm Beach GardensUnited StatesRecruiting
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesRecruiting
University of Pennsylvania
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PhiladelphiaUnited StatesRecruiting
University of Pittsburg
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PittsburghUnited StatesRecruiting
Allegheny-Singer Research Institute
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PittsburghUnited StatesRecruiting
Oregon Health Science University
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PortlandUnited StatesRecruiting
Virginia Commonwealth University
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RichmondUnited StatesRecruiting
The Valley Hospital Inc.
Coordinator of this site? Confirm its status
RidgewoodUnited StatesRecruiting
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting
St. Mark's Hospital
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting
Geisinger Commonwealth School of Medicine
Coordinator of this site? Confirm its status
ScrantonUnited StatesRecruiting
University of Washington
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting
Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC
Coordinator of this site? Confirm its status
South PasadenaUnited StatesNot yet recruiting
University of South Florida
Coordinator of this site? Confirm its status
TampaUnited StatesRecruiting
University of Arizona College of Medicine- Phoenix
Coordinator of this site? Confirm its status
TucsonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.