Recruiting

Left vs. LeftLeft vs Left Randomized Clinical Trial

Sponsor:

Baylor College of Medicine

Code:

NCT05650658

Conditions

Heart Failure

Heart Failure With Reduced Ejection Fraction

AV Block

LBBB

RBBB

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

His/LBBP

BiVP

Study Details

Brief summary:

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

Heart Failure

Heart Failure With Reduced Ejection Fraction

AV Block

LBBB

RBBB

Study ID

NCT05650658

Start date

Sep 13, 2023

Status verified date

Sep, 2025

Completion date

Jun 30, 2029

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: His/Left Bundle Branch Pacing (His/LBBP)

Patients with LVEF≤35% at entry will receive a His/LBB defibrillator which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular ICD lead, and an endocardial His-bundle or left bundle branch pacing lead directly pacing the intrinsic conduction system.

Patients with LVEF 36-50% at entry will receive His/LBB pacemaker which includes implantation of two leads, an endocardial right atrial lead, and an endocardial His-bundle or left bundle branch pacing lead directly pacing the intrinsic conduction system.

active comparator: Biventricular Pacing (BiVP)

Patients with LVEF≤35% at entry will receive a BiV defibrillator which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular ICD lead, and and an epicardial left ventricular lead implanted in a branch of the coronary sinus.

Patients with LVEF 36-50% at entry will receive BiV pacemaker which includes implantation of three leads, an endocardial right atrial lead, an endocardial right ventricular pacing lead, and and an epicardial left ventricular lead implanted in a branch of the coronary sinus.

Interventions

His/LBBP

Pacing at the level His-Bundle or left bundle branch is used to correct the underlying conduction abnormality, resulting in a faster and more homogeneous activation of the heart pacing directly via the intrinsic conduction system of the heart accompanied by a right atrial endocardial lead and a right ventricular defibrillator endocardial lead for LVEF≤35% and by a right atrial endocardial lead for LVEF 36-50%.

BiVP

Biventricular pacing has been shown to improve outcomes by delivering synchronized electrical stimuli to the right and left ventricles utilizing an an endocardial right atrial lead, an endocardial right ventricular lead, and an epicardial left ventricular lead implanted in a branch of the coronary sinus.

For LVEF≤35% a biventricular pacemaker-defibrillator will be implanted while for LVEF 36-50% a biventricular pacemaker will be implanted.

Primary outcome measure

A combined clinical endpoint of all-cause mortality and hospitalization for heart failure [ Time Frame: 5.5 years ]

Central Contacts and Locations

Central contacts

Mihail G Chelu, MD, PhD

7137987291 leftvsleft@bcm.edu

Merin Thomas

7137987291 merin.thomas@bcm.edu

Locations

Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ

Recruiting

Gilbert, Arizona, United States, 85297

Contacts

Jacqueline Killian

(480) 406-7231 jacqueline.killian@commonspirit.org

Principal Investigator:

Jaskanwal Bisla, MD

University of Arizona College of Medicine- Phoenix

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Raeven Maxwell

(312) 237-5891 Raeven.Maxwell@bannerhealth.com

Principal Investigator:

Michael Zawaneh, MD

University of Arkansas for Medical Sciences (UAMS)

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Urvashi Kalola

0000000000 ukalola@uams.edu

Principal Investigator:

Subodh Devabhaktuni, MD

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Jesus Gil

0000000000 jegil@health.ucsd.edu

Principal Investigator:

Farshad Raissi, MD

University of Colorado (Anschutz Medical Campus)

Recruiting

Denver, Colorado, United States, 80217

Contacts

Tanner Bloks

0000000000 tanner.bloks@cuanschutz.edu

Principal Investigator:

Matthew Zipse, MD

South Denver Cardiology Associates

Recruiting

Littleton, Colorado, United States, 80124

Contacts

Kathrin Siegel

(303) 703-2162 ksiegel@southdenver.com

Principal Investigator:

Srikanth Sundaram, MD

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Saskia Campbell

(860) 972-1558 Saskia.Campbell@hhchealth.org

Principal Investigator:

Eric Crespo, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Meg Leiss

0000000000 Margaret.leiss@yale.edu

Principal Investigator:

Mark Blitzer, MD

Heart Rhythm Solutions

Recruiting

Davie, Florida, United States, 33328

Contacts

Daniela Rodriguez

(954) 707-5200 Daniela@heartrhythmsolutions.com

Principal Investigator:

Awais K Humayun, MD

Cleveland Clinic Florida

Recruiting

Palm Beach Gardens, Florida, United States, 33418

Contacts

Maria Gomez Mejia

(954) 659-6204 MEJIAGM@ccf.org

Principal Investigator:

Ricardo Hernandez, MD

University of South Florida

Recruiting

Tampa, Florida, United States, 33613

Contacts

Jacky He

(813) 250-2462 jackyhe@usf.edu

Principal Investigator:

Bengt Herweg, MD

Rush University

Recruiting

Chicago, Illinois, United States, 60612

Principal Investigator:

Timothy Larsen, DO

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Principal Investigator:

Gaurav Upadhyay, MD

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

Katrina Martin

(312) 695-4067 katrina.martin@nm.org

Principal Investigator:

Nishant Verma, MD

Trustees of Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Molly Stearns

(317) 962-1130 mstearns2@IUHEALTH.ORG

Principal Investigator:

Antonio Navarrete, MD

Baptist Health Louisville

Recruiting

Louisville, Kentucky, United States, 40207

Contacts

Karin Cryan

0000000000 karin.cryan@BHSI.COM

Principal Investigator:

John Mandrola, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Chris Azzam

0000000000 cazzam@MGH.HARVARD.EDU

Principal Investigator:

Shaan Khurshid, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Henry Xie

(617) 632-8956 hxie1@bidmc.harvard.edu

Principal Investigator:

Andrew Locke, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Axe M Ahmed

0000000000 Ahmed.Abdimajid@mayo.edu

Principal Investigator:

Yong-Mei Cha, MD

HMH Hospitals Corporation

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Stephanie Lynes

(732) 897-2871 stephanie.lynes@hmhn.org

Principal Investigator:

Taya Glotzer, MD

Virtua Health

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Marisa Brown

(856) 355-1226 Mbrown3@virtua.org

Principal Investigator:

Aatish Garg, MD

Newark Beth Israel Medical Center

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Patricia Policastro

(973) 926-8451 Patricia.Policastro@rwjbh.org

Principal Investigator:

David Man, MD

The Valley Hospital, Inc.

Recruiting

Ridgewood, New Jersey, United States, 07450

Contacts

Lauren Tedeschi

(201) 447-8453 ltedesc2@Valleyhealth.com

Principal Investigator:

Suneet Mittal, MD

Lovelace Medical Center

Recruiting

Albuquerque, New Mexico, United States, 87102

Principal Investigator:

Sean Mazer

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Penn Collins

(315) 481-7389 gpc4001@med.cornell.edu

Principal Investigator:

Jim Cheung, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Ugur Gurol

(646) 581-1360 Ugur.Gurol@mountsinai.org

Principal Investigator:

Jacob Koruth, MD

MH Mission Hospital LLLP- Asheville Cardiology Associates

Recruiting

Asheville, North Carolina, United States, 28803

Contacts

Olivia Lim

0000000000 olivia.lim@hcahealthcare.com

Principal Investigator:

Michael Manogue, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Elias Wen

0000000000 emwen@email.unc.edu

Principal Investigator:

Anil Gehi, MD

Novant Health

Recruiting

Charlotte, North Carolina, United States, 28204

Principal Investigator:

Thomas Kambur

The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Susanne Pasley

0000000000 Susanne.Pasley@thechristhospital.com

Principal Investigator:

Edward Schloss, MD

The MetroHealth System

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Pete Leo

(216) 778-2714 pleo@metrohealth.org

Principal Investigator:

Soufian Almahameed, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Raquel Rozich

0000000000 Rozichr@ccf.org

Principal Investigator:

Roy Chung, MD

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Liz Cannard

0000000000 cannarde@ohsu.edu

Principal Investigator:

Eric Stecker, MD

St. Luke's University Health Network

Recruiting

Allentown, Pennsylvania, United States, 18015

Contacts

Kyle McFadden

0000000000 Kyle.McFadden@sluhn.org

Principal Investigator:

Sudip Nanda, MD

Lehigh Valley Hospital Inc.

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Traci L Eichelberger

0000000000 Traci.Eichelberger@jefferson.edu

Principal Investigator:

Babak Borzognia, MD

Penn Medicine Lancaster General

Recruiting

Lancaster, Pennsylvania, United States, 17603

Contacts

Andrew Hershey

(717) 544-1412 Andrew.Hershey@pennmedicine.upenn.edu

Principal Investigator:

Matthew Bernabei, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mary Gnap

(215) 349-8446 Mary.Gnap@pennmedicine.upenn.edu

Principal Investigator:

Robert Schaller, MD

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator:

Behzad Pavri

Allegheny-Singer Research Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Minesh Lathia

(412) 359-8468 minesh.lathia@ahn.org

Principal Investigator:

Joshua Silverstein, MD

University of Pittsburg

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Sherry Pellegrino

(412) 647-8210 pellegrinosl@upmc.edu

Principal Investigator:

Krishna Kancharla, MD

Geisinger Commonwealth School of Medicine

Recruiting

Scranton, Pennsylvania, United States, 18510

Principal Investigator:

Jess Oren, MD

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Olivia Washington

(843) 792-0464 washoliv@musc.edu

Principal Investigator:

Anne Kroman, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Stephen Harold

(713) 798-7227 harold@bcm.edu

Principal Investigator:

Mihail Chelu, MD

St. Mark's Hospital

Recruiting

Salt Lake City, Utah, United States, 84124

Contacts

Pragyna Gundaboina

0000000000 Pragyna.Gundaboina@HCAhealthcare.com

Principal Investigator:

Nischala Nannapaneni, MD

University of Vermont

Recruiting

Burlington, Vermont, United States, 05402

Contacts

Sonja Baden

(802) 847-8833 Sonja.Baden@uvmhealth.org

Principal Investigator:

Daniel Lustgarten, MD

University of Virginia Health System

Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator:

Rohit Malhotra

Inova Heart and Vascular Institute

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Tracy Plummer

(703) 776-3567 tracy.plummer@inova.org

Principal Investigator:

Brett Atwater, MD

Sentara Healthcare

Recruiting

Newport News, Virginia, United States, 23606

Principal Investigator:

Erich Kiehl

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23284

Principal Investigator:

Jordana Kron, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Adele Stefanowicz

0000000000 amstef99@uw.edu

Principal Investigator:

Kristen Patton, MD

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada

Contacts

Munyura Yannick

0000000000 yannick.munyura@ubc.ca

Principal Investigator:

Jason Andrade, MD

Victoria Cardiac Arrhythmia Trials (VCAT) Inc.

Recruiting

Victoria, British Columbia, Canada

Contacts

Matthew Coxon

(250) 595-0400 mcoxon@catrials.org

Principal Investigator:

Laurence Sterns, MD

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada

Contacts

Stephanie Hobbs

0000000000 Stephanie.hobbs@nshealth.ca

Principal Investigator:

Ratika Parkash, MD

Hamilton Health Sciences (HHS)

Recruiting

Hamilton, Ontario, Canada

Contacts

Kiran Qamar

(905) 521-2100 qamarulisl@HHSC.CA

Principal Investigator:

Jorge Wong, MD

Newmarket Electrophysiology Research Group Inc. (NERG)

Recruiting

Newmarket, Ontario, Canada

Contacts

Lynn Nyman

(905) 895-4521 lnyman@southlake.ca

Principal Investigator:

Mouhannad Sadek, MD

University of Ottawa Heart Institute

Recruiting

Ottawa, Ontario, Canada

Contacts

Maitreya PATEL

0000000000 MaPatel@ottawaheart.ca

Principal Investigator:

Calum Redpath, MD

Sunnybrook Research Institute

Recruiting

Toronto, Ontario, Canada

Contacts

Ambreen Syeda

(416) 480-6100 ambreen.syeda@sunnybrook.ca

Principal Investigator:

Christopher Cheung, MD

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada

Contacts

François François

(514) 376-3330 Francois.Lemarbre@icm-mhi.org

Principal Investigator:

Alexandre Raymond-Paquin, MD

University of Calgary

Recruiting

Calgary, Canada

Principal Investigator:

Derek Exner

Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital

Recruiting

Kitchener, Canada

Principal Investigator:

Claus Rinne

Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital

Recruiting

Montreal, Canada

Principal Investigator:

Jacqueline Joza

Université Laval

Recruiting

Québec, Canada

Contacts

Marina Sanchez

(418) 656-8711 marina.sanchez.1@ulaval.ca

Principal Investigator:

Francois Philippon, MD

More Information

Sponsor

Baylor College of Medicine

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2025-10-02.