AzTrials
AzTrials

Heart FailureNCT05650658

Left vs Left Randomized Clinical Trial

A study testing His/LBBP and BiVP in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Baylor College of Medicine at 71 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
His/LBBP and BiVP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,136 participants
Where
71 sitesin 2 countries
Study dates
13 Sep 2023to 30 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

71 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Mihail G Chelu, MD, PhD contact

7137987291

leftvsleft@bcm.edu

Merin Thomas contact

7137987291

merin.thomas@bcm.edu

71 sites in 2 countries

United States57 sites, 57 recruiting

  • Lovelace Medical Center

    Albuquerque, New Mexico, 87102

    Zinai Tellez

    Sean Mazer

    Recruiting

  • St. Luke's University Health Network

    Allentown, Pennsylvania, 18015

    Kyle McFadden, 0000000000, Kyle.McFadden@sluhn.org

    Sudip Nanda, MD

    Recruiting

  • Lehigh Valley Hospital Inc.

    Allentown, Pennsylvania, 18103

    Traci L Eichelberger, 0000000000, Traci.Eichelberger@jefferson.edu

    Babak Borzognia, MD

    Recruiting

  • Texas Health Research & Education Institute

    Arlington, Texas, 76011

    Rebecca Wade, 0000000000, rebeccawade@texashealth.org

    Theodore Takata, MD

    Not yet recruiting

  • MH Mission Hospital LLLP- Asheville Cardiology Associates

    Asheville, North Carolina, 28803

    Olivia Lim, 0000000000, olivia.lim@hcahealthcare.com

    Michael Manogue, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Chris Azzam, 0000000000, cazzam@MGH.HARVARD.EDU

    Shaan Khurshid, MD

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

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

    Andrew Locke, MD

    Recruiting

  • University of Vermont

    Burlington, Vermont, 05402

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

    Daniel Lustgarten, MD

    Recruiting

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

    Elias Wen, 0000000000, emwen@email.unc.edu

    Anil Gehi, MD

    Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Olivia Washington, (843) 792-0464, washoliv@musc.edu

    Anne Kroman, MD

    Recruiting

  • Novant Health

    Charlotte, North Carolina, 28204

    Darren N Crawford

    Thomas Kambur

    Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

    Katie L Sullivan

    Rohit Malhotra

    Recruiting

  • Rush University

    Chicago, Illinois, 60612

    Nusrat Jahan

    Timothy Larsen, DO

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Shahram Sarrafi

    Gaurav Upadhyay, MD

    Recruiting

  • The Christ Hospital

    Cincinnati, Ohio, 45219

    Susanne Pasley, 0000000000, Susanne.Pasley@thechristhospital.com

    Edward Schloss, MD

    Recruiting

  • The MetroHealth System

    Cleveland, Ohio, 44109

    Pete Leo, (216) 778-2714, pleo@metrohealth.org

    Soufian Almahameed, MD

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Raquel Rozich, 0000000000, Rozichr@ccf.org

    Roy Chung, MD

    Recruiting

  • Heart Rhythm Solutions

    Davie, Florida, 33328

    Daniela Rodriguez, (954) 707-5200, Daniela@heartrhythmsolutions.com

    Awais K Humayun, MD

    Recruiting

  • University of Colorado (Anschutz Medical Campus)

    Denver, Colorado, 80217

    Tanner Bloks, 0000000000, tanner.bloks@cuanschutz.edu

    Matthew Zipse, MD

    Recruiting

  • Northwestern University

    Evanston, Illinois, 60208

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

    Nishant Verma, MD

    Recruiting

  • Inova Heart and Vascular Institute

    Falls Church, Virginia, 22042

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

    Brett Atwater, MD

    Recruiting

  • Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ

    Gilbert, Arizona, 85297

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

    Jaskanwal Bisla, MD

    Recruiting

  • Prisma Health-Upstate

    Greenville, South Carolina, 29605

    Prisma Health-Upstate Shrum, 0000000000, ann.shrum@prismahealth.org

    Adam Barnett, MD

    Not yet recruiting

  • HMH Hospitals Corporation

    Hackensack, New Jersey, 07601

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

    Taya Glotzer, MD

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06102

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

    Eric Crespo, MD

    Recruiting

  • Baylor College of Medicine

    Houston, Texas, 77030

    Stephen Harold, (713) 798-7227, harold@bcm.edu

    Mihail Chelu, MD

    Recruiting

  • Trustees of Indiana University

    Indianapolis, Indiana, 46202

    Molly Stearns, (317) 962-1130, mstearns2@IUHEALTH.ORG

    Antonio Navarrete, MD

    Recruiting

  • University of Florida Jacksonville

    Jacksonville, Florida, 32211

    Latonya Been, 0000000000, latonya.been@ufhealth.org

    Aditya Saini, MD

    Not yet recruiting

  • University of California San Diego

    La Jolla, California, 92093

    Jesus Gil, 0000000000, jegil@health.ucsd.edu

    Farshad Raissi, MD

    Recruiting

  • Penn Medicine Lancaster General

    Lancaster, Pennsylvania, 17603

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

    Matthew Bernabei, MD

    Recruiting

  • University of Arkansas for Medical Sciences (UAMS)

    Little Rock, Arkansas, 72205

    Urvashi Kalola, 0000000000, ukalola@uams.edu

    Subodh Devabhaktuni, MD

    Recruiting

  • South Denver Cardiology Associates

    Littleton, Colorado, 80124

    Kathrin Siegel, (303) 703-2162, ksiegel@southdenver.com

    Srikanth Sundaram, MD

    Recruiting

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

    Karin Cryan, 0000000000, karin.cryan@BHSI.COM

    John Mandrola, MD

    Recruiting

  • Virtua Health

    Marlton, New Jersey, 08053

    Marisa Brown, (856) 355-1226, Mbrown3@virtua.org

    Aatish Garg, MD

    Recruiting

  • Mount Sinai Medical Center of Florida, Inc.

    Miami Beach, Florida, 33140

    Giselle Cortez, 00000000000, Giselle.CortezVargas@msmc.com

    Jose Sleiman, MD

    Not yet recruiting

  • CIS Clinical Research Corporation

    Naperville, Illinois, 60540

    Enrolling by invitation

  • Yale University

    New Haven, Connecticut, 06511

    Meg Leiss, 0000000000, Margaret.leiss@yale.edu

    Mark Blitzer, MD

    Recruiting

  • Weill Cornell Medicine

    New York, New York, 10021

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

    Jim Cheung, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

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

    Jacob Koruth, MD

    Recruiting

  • Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)

    New York, New York, 10032

    Alicha Daniel, 0000000000, aad2223@cumc.columbia.edu

    Ellie Coronmilas, MD

    Not yet recruiting

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

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

    David Man, MD

    Recruiting

  • Sentara Healthcare

    Newport News, Virginia, 23606

    Linette Klevan

    Erich Kiehl

    Recruiting

  • Cleveland Clinic Florida

    Palm Beach Gardens, Florida, 33418

    Maria Gomez Mejia, (954) 659-6204, MEJIAGM@ccf.org

    Ricardo Hernandez, MD

    Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

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

    Robert Schaller, MD

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Mckenna Krall

    Behzad Pavri

    Recruiting

  • Allegheny-Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

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

    Joshua Silverstein, MD

    Recruiting

  • University of Pittsburg

    Pittsburgh, Pennsylvania, 15213

    Sherry Pellegrino, (412) 647-8210, pellegrinosl@upmc.edu

    Krishna Kancharla, MD

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Liz Cannard, 0000000000, cannarde@ohsu.edu

    Eric Stecker, MD

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23284

    Melissa Sears

    Jordana Kron, MD

    Recruiting

  • The Valley Hospital, Inc.

    Ridgewood, New Jersey, 07450

    Lauren Tedeschi, (201) 447-8453, ltedesc2@Valleyhealth.com

    Suneet Mittal, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Axe M Ahmed, 0000000000, Ahmed.Abdimajid@mayo.edu

    Yong-Mei Cha, MD

    Recruiting

  • St. Mark's Hospital

    Salt Lake City, Utah, 84124

    Pragyna Gundaboina, 0000000000, Pragyna.Gundaboina@HCAhealthcare.com

    Nischala Nannapaneni, MD

    Recruiting

  • Geisinger Commonwealth School of Medicine

    Scranton, Pennsylvania, 18510

    Grace E Hughes

    Jess Oren, MD

    Recruiting

  • University of Washington

    Seattle, Washington, 98195

    Adele Stefanowicz, 0000000000, amstef99@uw.edu

    Kristen Patton, MD

    Recruiting

  • Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC

    South Pasadena, Florida, 33707

    Adryanna Alban, 0000000000, adryanna.alban@flahrs.com

    David Kenigsberg, MD

    Not yet recruiting

  • University of South Florida

    Tampa, Florida, 33613

    Jacky He, (813) 250-2462, jackyhe@usf.edu

    Bengt Herweg, MD

    Recruiting

  • University of Arizona College of Medicine- Phoenix

    Tucson, Arizona, 85719

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

    Michael Zawaneh, MD

    Recruiting

Other trials in United States

Canada14 sites, 14 recruiting

  • University of Calgary

    Calgary

    Nirav Bhagat

    Derek Exner

    Recruiting

  • Mazankowski Alberta Heart Institute/University of Alberta

    Edmonton, Alberta

    Lee-Ann Langkaas, 0000000000, Lee-Ann.Langkaas@albertahealthservices.ca

    Evan Martow, MD

    Not yet recruiting

  • Nova Scotia Health Authority

    Halifax, Nova Scotia

    Stephanie Hobbs, 0000000000, Stephanie.hobbs@nshealth.ca

    Ratika Parkash, MD

    Recruiting

  • Hamilton Health Sciences (HHS)

    Hamilton, Ontario

    Kiran Qamar, (905) 521-2100, qamarulisl@HHSC.CA

    Jorge Wong, MD

    Recruiting

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

    Kitchener

    Mary Radyk

    Claus Rinne

    Recruiting

  • Montreal Heart Institute

    Montreal, Quebec

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

    Alexandre Raymond-Paquin, MD

    Recruiting

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

    Montreal

    Fiorella Rafti

    Jacqueline Joza

    Recruiting

  • Newmarket Electrophysiology Research Group Inc. (NERG)

    Newmarket, Ontario

    Lynn Nyman, (905) 895-4521, lnyman@southlake.ca

    Mouhannad Sadek, MD

    Recruiting

  • University of Ottawa Heart Institute

    Ottawa, Ontario

    Maitreya PATEL, 0000000000, MaPatel@ottawaheart.ca

    Calum Redpath, MD

    Recruiting

  • Université Laval

    Québec

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

    Francois Philippon, MD

    Recruiting

  • CIUSSS de l'Estrie - CHUS

    Saint-Jean-sur-Richelieu, Quebec

    Marie-Claude Grenier, 0000000000, marie-claude.grenier.ciussse-chus@ssss.gouv.qc.ca

    Félix Ayala-Paredes, MD

    Not yet recruiting

  • Sunnybrook Research Institute

    Toronto, Ontario

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

    Christopher Cheung, MD

    Recruiting

  • University of British Columbia

    Vancouver, British Columbia

    Munyura Yannick, 0000000000, yannick.munyura@ubc.ca

    Jason Andrade, MD

    Recruiting

  • Victoria Cardiac Arrhythmia Trials (VCAT) Inc.

    Victoria, British Columbia

    Matthew Coxon, (250) 595-0400, mcoxon@catrials.org

    Laurence Sterns, MD

    Recruiting

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

In this prospective, randomized, multi-center clinical trial, the investigators aim to prospectively evaluate the comparative effectiveness His or Left bundle branch pacing (His/LBBP) vs. biventricular pacing (BiVP) 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 by assessing all cause death and heart failure hospitalization at the end of the study.

Additional formal secondary objectives include evaluation disease-specific quality and psychological adjustment changes at 1 year after device implant and evaluation of a composite of death of any cause or heart failure hospitalization or more >15% increase in the left ventricular end-systolic volume index at the end of the study.

Being tested
His/LBBP, BiVP
Medical subject headings
Heart Failure, Atrioventricular Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • His/LBBPDevice

    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%.

  • BiVPDevice

    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.

Study groups in NCT05650658
Study groupRoleWhat they receive
His/Left Bundle Branch Pacing (His/LBBP)Active comparatorPatients 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.
Receives: Device: His/LBBP
Biventricular Pacing (BiVP)Active comparatorPatients 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.
Receives: Device: BiVP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A combined clinical endpoint of all-cause mortality and hospitalization for heart failure

    The primary efficacy outcome will be described using Kaplan-Meier freedom from event curves over time, with event-free survival compared between assigned treatment arms using a logrank test, stratified by levels of the two factors (LVEF (≤35% vs. 36 to 50%) and conduction abnormality (LBBB vs non-LBBB)) used for randomization.

    Measured: 5.5 years

Secondary outcomes (14)

  1. Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at 12 months

    Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) item score measured before and at 12 months after implant.

    Measured: 12 months

  2. Change in composite endpoint comprised of death, first hospitalization for worsening HF and left ventricular end systolic volume index (LVESVi) at 5.5 years

    Secondary endpoint measured from all cause death, first hospitalization for heart failure and echocardiography on left ventricular end-systolic volume index (LVESVi) in the His/LBBP vs. BIV-BiVP arm

    Measured: 5.5 years

  3. Composite of cardiovascular death or heart transplant or durable left ventricular assist device or more > 15% increase in the LVESVi or change in KCCQ-12 at the end of the study using win ratio

    Secondary endpoint measured from cardiovascular death or heart transplant or durable left ventricular assist device or more > 15% increase in the LVESVi or change in KCCQ-12 at the end of the study using win ratio

    Measured: 5.5 years

  4. Death from any cause at 5.5 years

    Secondary endpoint measured from all cause death

    Measured: 5.5 years

  5. Death from any cardiovascular cause at 5.5 years

    Secondary endpoint measured from death due to cardiovascular causes

    Measured: 5.5 years

  6. Hospitalization for heart failure at 5.5 years

    Secondary endpoint measured from first hospitalization for heart failure

    Measured: 5.5 years

  7. Cardiovascular hospitalization at 5.5 years

    Secondary endpoint measured from first hospitalization for cardiovascular disease

    Measured: 5.5 years

  8. Total HF hospitalizations

    Total number of HF hospitalizations

    Measured: 5.5 years

  9. Composite of cardiovascular death or first HF hospitalization

    Secondary endpoint measured from cardiovascular death, first hospitalization for heart failure

    Measured: 5.5 years

  10. Composite cardiovascular death or HF hospitalization or heart transplant or durable left ventricular assist device

    Secondary endpoint measured from cardiovascular death, heart transplant or durable left ventricular assist device

    Measured: 5.5 years

  11. Change in NYHA Classification at 12 months

    Secondary endpoint measured from New York Heart Association class

    Measured: 12 months

  12. Change in Six Minute Walk Test performance at 12 months

    Secondary endpoint measured from Six Minute Walk Test

    Measured: 12 months

  13. Patient activity measured through cardiovascular implantable electronic devices (CIED) at 12 months

    Measurement Patient activity measured through cardiovascular implantable electronic devices (CIED)

    Measured: 12 months

  14. Change in NT-proBNP at 12 months

    Measurement of heart failure serum biomarker NT-proBNP

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2022
  2. Study start13 Sep 2023
  3. Primary completion30 Jun 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
2,136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05650658
Sponsor's protocol ID
PLACER 2021C3- 24160
Status last verified
Sep 2025
First submitted
24 Nov 2022
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Abe TA, Evbayekha EO, Jackson LR 2nd, Al-Khatib SM, Lewsey SC, Breathett K. Evolving Indications, Challenges and Advances in Cardiac Resynchronization Therapy for Heart Failure. J Card Fail. 2026 Feb;32(2):499-514. doi: 10.1016/j.cardfail.2025.01.031. Epub 2025 Apr 16.

    PubMed 40250827

  • Infeld M, Cyr JA, Sanchez-Quintana D, Madias C, Udelson JE, Lustgarten DL, Meyer M. Physiological Pacing for the Prevention and Treatment of Heart Failure: a State-of-the-Art Review. J Card Fail. 2024 Dec;30(12):1614-1628. doi: 10.1016/j.cardfail.2024.08.063. Epub 2024 Oct 29.

    PubMed 39481799

Questions about this trial

What is this clinical trial studying?

A study testing His/LBBP and BiVP in people with Heart Failure and Heart Failure With Reduced Ejection Fraction, run by Baylor College of Medicine at 71 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mihail G Chelu, MD, PhD (7137987291, leftvsleft@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A combined clinical endpoint of all-cause mortality and hospitalization for heart failure (time frame: 5.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05650658, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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Left vs Left Randomized Clinical Trial (NCT05650658) | AzTrials