Left vs Left Randomized Clinical Trial

September 28, 2025 updated by: Mihail Gabriel Chelu, Baylor College of Medicine

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

2136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Calgary, Canada
        • Recruiting
        • University Of Calgary
        • Contact:
          • Nirav Bhagat
        • Principal Investigator:
          • Derek Exner
      • Kitchener, Canada
        • Recruiting
        • Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital
        • Contact:
          • Mary Radyk
        • Principal Investigator:
          • Claus Rinne
      • Montreal, Canada
        • Recruiting
        • Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital
        • Principal Investigator:
          • Jacqueline Joza
        • Contact:
          • Fiorella Rafti
      • Québec, Canada
        • Recruiting
        • Université Laval
        • Principal Investigator:
          • Francois Philippon, MD
        • Contact:
    • Alberta
      • Edmonton, Alberta, Canada
        • Not yet recruiting
        • Mazankowski Alberta Heart Institute/University of Alberta
        • Contact:
        • Principal Investigator:
          • Evan Martow, MD
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • University of British Columbia
        • Principal Investigator:
          • Jason Andrade, MD
        • Contact:
      • Victoria, British Columbia, Canada
        • Recruiting
        • Victoria Cardiac Arrhythmia Trials (VCAT) Inc.
        • Principal Investigator:
          • Laurence Sterns, MD
        • Contact:
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Recruiting
        • Nova Scotia Health Authority
        • Principal Investigator:
          • Ratika Parkash, MD
        • Contact:
    • Ontario
      • Hamilton, Ontario, Canada
        • Recruiting
        • Hamilton Health Sciences (HHS)
        • Principal Investigator:
          • Jorge Wong, MD
        • Contact:
      • Newmarket, Ontario, Canada
        • Recruiting
        • Newmarket Electrophysiology Research Group Inc. (NERG)
        • Principal Investigator:
          • Mouhannad Sadek, MD
        • Contact:
      • Ottawa, Ontario, Canada
        • Recruiting
        • University of Ottawa Heart Institute
        • Contact:
        • Principal Investigator:
          • Calum Redpath, MD
      • Toronto, Ontario, Canada
        • Recruiting
        • Sunnybrook Research Institute
        • Principal Investigator:
          • Christopher Cheung, MD
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • Montreal Heart Institute
        • Contact:
        • Principal Investigator:
          • Alexandre Raymond-Paquin, MD
      • Saint-Jean-sur-Richelieu, Quebec, Canada
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ
        • Principal Investigator:
          • Jaskanwal Bisla, MD
        • Contact:
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona College of Medicine- Phoenix
        • Contact:
        • Principal Investigator:
          • Michael Zawaneh, MD
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas for Medical Sciences (UAMS)
        • Contact:
        • Principal Investigator:
          • Subodh Devabhaktuni, MD
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego
        • Contact:
        • Principal Investigator:
          • Farshad Raissi, MD
    • Colorado
      • Denver, Colorado, United States, 80217
        • Recruiting
        • University of Colorado (Anschutz Medical Campus)
        • Contact:
        • Principal Investigator:
          • Matthew Zipse, MD
      • Littleton, Colorado, United States, 80124
        • Recruiting
        • South Denver Cardiology Associates
        • Principal Investigator:
          • Srikanth Sundaram, MD
        • Contact:
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Recruiting
        • Hartford Hospital
        • Principal Investigator:
          • Eric Crespo, MD
        • Contact:
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Yale University
        • Contact:
        • Principal Investigator:
          • Mark Blitzer, MD
    • Florida
      • Davie, Florida, United States, 33328
        • Recruiting
        • Heart Rhythm Solutions
        • Contact:
        • Principal Investigator:
          • Awais K Humayun, MD
      • Jacksonville, Florida, United States, 32211
        • Not yet recruiting
        • University of Florida Jacksonville
        • Contact:
        • Principal Investigator:
          • Aditya Saini, MD
      • Miami Beach, Florida, United States, 33140
        • Not yet recruiting
        • Mount Sinai Medical Center of Florida, Inc.
        • Contact:
        • Principal Investigator:
          • Jose Sleiman, MD
      • Palm Beach Gardens, Florida, United States, 33418
        • Recruiting
        • Cleveland Clinic Florida
        • Principal Investigator:
          • Ricardo Hernandez, MD
        • Contact:
      • South Pasadena, Florida, United States, 33707
        • Not yet recruiting
        • Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC
        • Principal Investigator:
          • David Kenigsberg, MD
        • Contact:
      • Tampa, Florida, United States, 33613
        • Recruiting
        • University of South Florida
        • Contact:
        • Principal Investigator:
          • Bengt Herweg, MD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
          • Shahram Sarrafi
        • Principal Investigator:
          • Gaurav Upadhyay, MD
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University
        • Contact:
          • Nusrat Jahan
        • Principal Investigator:
          • Timothy Larsen, DO
      • Evanston, Illinois, United States, 60208
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Nishant Verma, MD
      • Naperville, Illinois, United States, 60540
        • Enrolling by invitation
        • CIS Clinical Research Corporation
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Trustees of Indiana University
        • Principal Investigator:
          • Antonio Navarrete, MD
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Recruiting
        • Baptist Health Louisville
        • Contact:
        • Principal Investigator:
          • John Mandrola, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Shaan Khurshid, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Andrew Locke, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Yong-Mei Cha, MD
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • HMH Hospitals Corporation
        • Contact:
        • Principal Investigator:
          • Taya Glotzer, MD
      • Marlton, New Jersey, United States, 08053
        • Recruiting
        • Virtua Health
        • Contact:
        • Principal Investigator:
          • Aatish Garg, MD
      • Newark, New Jersey, United States, 07112
        • Recruiting
        • Newark Beth Israel Medical Center
        • Contact:
        • Principal Investigator:
          • David Man, MD
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • The Valley Hospital, Inc.
        • Principal Investigator:
          • Suneet Mittal, MD
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Lovelace Medical Center
        • Contact:
          • Zinai Tellez
        • Principal Investigator:
          • Sean Mazer
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine
        • Principal Investigator:
          • Jim Cheung, MD
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School Of Medicine At Mount Sinai
        • Principal Investigator:
          • Jacob Koruth, MD
        • Contact:
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)
        • Contact:
        • Principal Investigator:
          • Ellie Coronmilas, MD
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • MH Mission Hospital LLLP- Asheville Cardiology Associates
        • Contact:
        • Principal Investigator:
          • Michael Manogue, MD
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Principal Investigator:
          • Anil Gehi, MD
        • Contact:
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health
        • Contact:
          • Darren N Crawford
        • Principal Investigator:
          • Thomas Kambur
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Roy Chung, MD
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • The MetroHealth System
        • Contact:
        • Principal Investigator:
          • Soufian Almahameed, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Eric Stecker, MD
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18015
        • Recruiting
        • St. Luke's University Health Network
        • Contact:
        • Principal Investigator:
          • Sudip Nanda, MD
      • Allentown, Pennsylvania, United States, 18103
        • Recruiting
        • Lehigh Valley Hospital Inc.
        • Contact:
        • Principal Investigator:
          • Babak Borzognia, MD
      • Lancaster, Pennsylvania, United States, 17603
        • Recruiting
        • Penn Medicine Lancaster General
        • Principal Investigator:
          • Matthew Bernabei, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Principal Investigator:
          • Robert Schaller, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Contact:
          • Mckenna Krall
        • Principal Investigator:
          • Behzad Pavri
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny-Singer Research Institute
        • Principal Investigator:
          • Joshua Silverstein, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburg
        • Principal Investigator:
          • Krishna Kancharla, MD
        • Contact:
      • Scranton, Pennsylvania, United States, 18510
        • Recruiting
        • Geisinger Commonwealth School of Medicine
        • Contact:
          • Grace E Hughes
        • Principal Investigator:
          • Jess Oren, MD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina (MUSC)
        • Contact:
        • Principal Investigator:
          • Anne Kroman, MD
      • Greenville, South Carolina, United States, 29605
        • Not yet recruiting
        • Prisma Health-Upstate
        • Contact:
        • Principal Investigator:
          • Adam Barnett, MD
    • Texas
      • Arlington, Texas, United States, 76011
        • Not yet recruiting
        • Texas Health Research & Education Institute
        • Contact:
        • Principal Investigator:
          • Theodore Takata, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Principal Investigator:
          • Mihail Chelu, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84124
    • Vermont
      • Burlington, Vermont, United States, 05402
        • Recruiting
        • University of Vermont
        • Contact:
        • Principal Investigator:
          • Daniel Lustgarten, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Health System
        • Principal Investigator:
          • Rohit Malhotra
        • Contact:
          • Katie L Sullivan
      • Falls Church, Virginia, United States, 22042
        • Recruiting
        • Inova Heart and Vascular Institute
        • Principal Investigator:
          • Brett Atwater, MD
        • Contact:
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • Sentara Healthcare
        • Contact:
          • Linette Klevan
        • Principal Investigator:
          • Erich Kiehl
      • Richmond, Virginia, United States, 23284
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Jordana Kron, MD
        • Contact:
          • Melissa Sears
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
        • Principal Investigator:
          • Kristen Patton, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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%.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A combined clinical endpoint of all-cause mortality and hospitalization for heart failure
Time Frame: 5.5 years
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.
5.5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) at 12 months
Time Frame: 12 months
Assess change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) item score measured before and at 12 months after implant.
12 months
Change in composite endpoint comprised of death, first hospitalization for worsening HF and left ventricular end systolic volume index (LVESVi) at 5.5 years
Time Frame: 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
5.5 years
Death from any cause at 5.5 years
Time Frame: 5.5 years
Secondary endpoint measured from all cause death
5.5 years
Death from any cardiovascular cause at 5.5 years
Time Frame: 5.5 years
Secondary endpoint measured from death due to cardiovascular causes
5.5 years
Hospitalization for heart failure at 5.5 years
Time Frame: 5.5 years
Secondary endpoint measured from first hospitalization for heart failure
5.5 years
Cardiovascular hospitalization at 5.5 years
Time Frame: 5.5 years
Secondary endpoint measured from first hospitalization for cardiovascular disease
5.5 years
Change in NYHA Classification at 12 months
Time Frame: 12 months
Secondary endpoint measured from New York Heart Association class
12 months
Change in Six Minute Walk Test performance at 12 months
Time Frame: 12 months
Secondary endpoint measured from Six Minute Walk Test
12 months
Change in NT-proBNP at 12 months
Time Frame: 12 months
Measurement of heart failure serum biomarker NT-proBNP
12 months
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
Time Frame: 5.5 years
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
5.5 years
Total HF hospitalizations
Time Frame: 5.5 years
Total number of HF hospitalizations
5.5 years
Composite of cardiovascular death or first HF hospitalization
Time Frame: 5.5 years
Secondary endpoint measured from cardiovascular death, first hospitalization for heart failure
5.5 years
Composite cardiovascular death or HF hospitalization or heart transplant or durable left ventricular assist device
Time Frame: 5.5 years
Secondary endpoint measured from cardiovascular death, heart transplant or durable left ventricular assist device
5.5 years
Patient activity measured through cardiovascular implantable electronic devices (CIED) at 12 months
Time Frame: 12 months
Measurement Patient activity measured through cardiovascular implantable electronic devices (CIED)
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appropriate ICD therapy for ventricular arrhythmias
Time Frame: 5.5 years
Antitachycardia pacing or ICD shocks
5.5 years
Change in Left Ventricular Ejection Fraction (LVEF) at 12 months
Time Frame: 12 months
Measurement of LVEF before and at 12 months after implant using echocardiography
12 months
Incidence of atrial tachyarrhythmia events
Time Frame: 5.5 years
Atrial arrhythmia event measured through cIED
5.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

Patient-Centered Outcomes Research Institute
University of Utah
Virginia Commonwealth University
East Carolina University
Cleveland Clinic Florida

Investigators

  • Principal Investigator: Mihail G Chelu, MD, PhD, Baylor College of Medicine
  • Principal Investigator: Kenneth A Ellenbogen, MD, Virginia Commonwealth University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2023

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

November 24, 2022

First Submitted That Met QC Criteria

December 6, 2022

First Posted (Actual)

December 14, 2022

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 28, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLACER 2021C3- 24160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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