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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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 sites (57)
AR
- University of Arkansas for Medical Sciences (UAMS) · Little Rock, AR 72205Urvashi Kalola · Study contact · 0000000000 · ukalola@uams.eduSubodh Devabhaktuni, MD · Principal investigatorMore trials in Little Rock
AZ
- Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ · Gilbert, AZ 85297Jacqueline Killian · Study contact · (480) 406-7231 · jacqueline.killian@commonspirit.orgJaskanwal Bisla, MD · Principal investigatorMore trials in Gilbert
- University of Arizona College of Medicine- Phoenix · Tucson, AZ 85719Raeven Maxwell · Study contact · (312) 237-5891 · Raeven.Maxwell@bannerhealth.comMichael Zawaneh, MD · Principal investigatorMore trials in Tucson
CA
- University of California San Diego · La Jolla, CA 92093Jesus Gil · Study contact · 0000000000 · jegil@health.ucsd.eduFarshad Raissi, MD · Principal investigatorMore trials in La Jolla
CO
- University of Colorado (Anschutz Medical Campus) · Denver, CO 80217Tanner Bloks · Study contact · 0000000000 · tanner.bloks@cuanschutz.eduMatthew Zipse, MD · Principal investigatorMore trials in Denver
- South Denver Cardiology Associates · Littleton, CO 80124Kathrin Siegel · Study contact · (303) 703-2162 · ksiegel@southdenver.comSrikanth Sundaram, MD · Principal investigatorMore trials in Littleton
CT
- Hartford Hospital · Hartford, CT 06102Saskia Campbell · Study contact · (860) 972-1558 · Saskia.Campbell@hhchealth.orgEric Crespo, MD · Principal investigatorMore trials in Hartford
- Yale University · New Haven, CT 06511Meg Leiss · Study contact · 0000000000 · Margaret.leiss@yale.eduMark Blitzer, MD · Principal investigatorMore trials in New Haven
FL
- Heart Rhythm Solutions · Davie, FL 33328Daniela Rodriguez · Study contact · (954) 707-5200 · Daniela@heartrhythmsolutions.comAwais K Humayun, MD · Principal investigatorMore trials in Davie
- University of Florida Jacksonville · Jacksonville, FL 32211Latonya Been · Study contact · 0000000000 · latonya.been@ufhealth.orgAditya Saini, MD · Principal investigatorMore trials in Jacksonville
- Mount Sinai Medical Center of Florida, Inc. · Miami Beach, FL 33140Giselle Cortez · Study contact · 00000000000 · Giselle.CortezVargas@msmc.comJose Sleiman, MD · Principal investigatorMore trials in Miami Beach
- Cleveland Clinic Florida · Palm Beach Gardens, FL 33418Maria Gomez Mejia · Study contact · (954) 659-6204 · MEJIAGM@ccf.orgRicardo Hernandez, MD · Principal investigatorMore trials in Palm Beach Gardens
- Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC · South Pasadena, FL 33707Adryanna Alban · Study contact · 0000000000 · adryanna.alban@flahrs.comDavid Kenigsberg, MD · Principal investigatorMore trials in South Pasadena
- University of South Florida · Tampa, FL 33613Jacky He · Study contact · (813) 250-2462 · jackyhe@usf.eduBengt Herweg, MD · Principal investigatorMore trials in Tampa
IL
- Rush University · Chicago, IL 60612Nusrat Jahan · Study contactTimothy Larsen, DO · Principal investigatorMore trials in Chicago
- University of Chicago · Chicago, IL 60637Shahram Sarrafi · Study contactGaurav Upadhyay, MD · Principal investigatorMore trials in Chicago
- Northwestern University · Evanston, IL 60208Katrina Martin · Study contact · (312) 695-4067 · katrina.martin@nm.orgNishant Verma, MD · Principal investigatorMore trials in Evanston
- CIS Clinical Research Corporation · Naperville, IL 60540More trials in Naperville
IN
- Trustees of Indiana University · Indianapolis, IN 46202Molly Stearns · Study contact · (317) 962-1130 · mstearns2@IUHEALTH.ORGAntonio Navarrete, MD · Principal investigatorMore trials in Indianapolis
KY
- Baptist Health Louisville · Louisville, KY 40207Karin Cryan · Study contact · 0000000000 · karin.cryan@BHSI.COMJohn Mandrola, MD · Principal investigatorMore trials in Louisville
MA
- Massachusetts General Hospital · Boston, MA 02114Chris Azzam · Study contact · 0000000000 · cazzam@MGH.HARVARD.EDUShaan Khurshid, MD · Principal investigatorMore trials in Boston
- Beth Israel Deaconess Medical Center · Boston, MA 02215Henry Xie · Study contact · (617) 632-8956 · hxie1@bidmc.harvard.eduAndrew Locke, MD · Principal investigatorMore trials in Boston
MN
- Mayo Clinic · Rochester, MN 55905Axe M Ahmed · Study contact · 0000000000 · Ahmed.Abdimajid@mayo.eduYong-Mei Cha, MD · Principal investigatorMore trials in Rochester
NC
- MH Mission Hospital LLLP- Asheville Cardiology Associates · Asheville, NC 28803Olivia Lim · Study contact · 0000000000 · olivia.lim@hcahealthcare.comMichael Manogue, MD · Principal investigatorMore trials in Asheville
- University of North Carolina · Chapel Hill, NC 27599Elias Wen · Study contact · 0000000000 · emwen@email.unc.eduAnil Gehi, MD · Principal investigatorMore trials in Chapel Hill
- Novant Health · Charlotte, NC 28204Darren N Crawford · Study contactThomas Kambur · Principal investigatorMore trials in Charlotte
NJ
- HMH Hospitals Corporation · Hackensack, NJ 07601Stephanie Lynes · Study contact · (732) 897-2871 · stephanie.lynes@hmhn.orgTaya Glotzer, MD · Principal investigatorMore trials in Hackensack
- Virtua Health · Marlton, NJ 08053Marisa Brown · Study contact · (856) 355-1226 · Mbrown3@virtua.orgAatish Garg, MD · Principal investigatorMore trials in Marlton
- Newark Beth Israel Medical Center · Newark, NJ 07112Patricia Policastro · Study contact · (973) 926-8451 · Patricia.Policastro@rwjbh.orgDavid Man, MD · Principal investigatorMore trials in Newark
- The Valley Hospital, Inc. · Ridgewood, NJ 07450Lauren Tedeschi · Study contact · (201) 447-8453 · ltedesc2@Valleyhealth.comSuneet Mittal, MD · Principal investigatorMore trials in Ridgewood
NM
- Lovelace Medical Center · Albuquerque, NM 87102Zinai Tellez · Study contactSean Mazer · Principal investigatorMore trials in Albuquerque
NY
- Weill Cornell Medicine · New York, NY 10021Penn Collins · Study contact · (315) 481-7389 · gpc4001@med.cornell.eduJim Cheung, MD · Principal investigatorMore trials in New York
- Icahn School of Medicine at Mount Sinai · New York, NY 10029Ugur Gurol · Study contact · (646) 581-1360 · Ugur.Gurol@mountsinai.orgJacob Koruth, MD · Principal investigatorMore trials in New York
- Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH) · New York, NY 10032Alicha Daniel · Study contact · 0000000000 · aad2223@cumc.columbia.eduEllie Coronmilas, MD · Principal investigatorMore trials in New York
OH
- The Christ Hospital · Cincinnati, OH 45219Susanne Pasley · Study contact · 0000000000 · Susanne.Pasley@thechristhospital.comEdward Schloss, MD · Principal investigatorMore trials in Cincinnati
- The MetroHealth System · Cleveland, OH 44109Pete Leo · Study contact · (216) 778-2714 · pleo@metrohealth.orgSoufian Almahameed, MD · Principal investigatorMore trials in Cleveland
- Cleveland Clinic · Cleveland, OH 44195Raquel Rozich · Study contact · 0000000000 · Rozichr@ccf.orgRoy Chung, MD · Principal investigatorMore trials in Cleveland
OR
- Oregon Health & Science University · Portland, OR 97239Liz Cannard · Study contact · 0000000000 · cannarde@ohsu.eduEric Stecker, MD · Principal investigatorMore trials in Portland
PA
- St. Luke's University Health Network · Allentown, PA 18015Kyle McFadden · Study contact · 0000000000 · Kyle.McFadden@sluhn.orgSudip Nanda, MD · Principal investigatorMore trials in Allentown
- Lehigh Valley Hospital Inc. · Allentown, PA 18103Traci L Eichelberger · Study contact · 0000000000 · Traci.Eichelberger@jefferson.eduBabak Borzognia, MD · Principal investigatorMore trials in Allentown
- Penn Medicine Lancaster General · Lancaster, PA 17603Andrew Hershey · Study contact · (717) 544-1412 · Andrew.Hershey@pennmedicine.upenn.eduMatthew Bernabei, MD · Principal investigatorMore trials in Lancaster
- University of Pennsylvania · Philadelphia, PA 19104Mary Gnap · Study contact · (215) 349-8446 · Mary.Gnap@pennmedicine.upenn.eduRobert Schaller, MD · Principal investigatorMore trials in Philadelphia
- Thomas Jefferson University Hospital · Philadelphia, PA 19107Mckenna Krall · Study contactBehzad Pavri · Principal investigatorMore trials in Philadelphia
- Allegheny-Singer Research Institute · Pittsburgh, PA 15212Minesh Lathia · Study contact · (412) 359-8468 · minesh.lathia@ahn.orgJoshua Silverstein, MD · Principal investigatorMore trials in Pittsburgh
- University of Pittsburg · Pittsburgh, PA 15213Sherry Pellegrino · Study contact · (412) 647-8210 · pellegrinosl@upmc.eduKrishna Kancharla, MD · Principal investigatorMore trials in Pittsburgh
- Geisinger Commonwealth School of Medicine · Scranton, PA 18510Grace E Hughes · Study contactJess Oren, MD · Principal investigatorMore trials in Scranton
SC
- Medical University of South Carolina (MUSC) · Charleston, SC 29425Olivia Washington · Study contact · (843) 792-0464 · washoliv@musc.eduAnne Kroman, MD · Principal investigatorMore trials in Charleston
- Prisma Health-Upstate · Greenville, SC 29605Prisma Health-Upstate Shrum · Study contact · 0000000000 · ann.shrum@prismahealth.orgAdam Barnett, MD · Principal investigatorMore trials in Greenville
TX
- Texas Health Research & Education Institute · Arlington, TX 76011Rebecca Wade · Study contact · 0000000000 · rebeccawade@texashealth.orgTheodore Takata, MD · Principal investigatorMore trials in Arlington
- Baylor College of Medicine · Houston, TX 77030Stephen Harold · Study contact · (713) 798-7227 · harold@bcm.eduMihail Chelu, MD · Principal investigatorMore trials in Houston
UT
- St. Mark's Hospital · Salt Lake City, UT 84124Pragyna Gundaboina · Study contact · 0000000000 · Pragyna.Gundaboina@HCAhealthcare.comNischala Nannapaneni, MD · Principal investigatorMore trials in Salt Lake City
VA
- University of Virginia Health System · Charlottesville, VA 22908Katie L Sullivan · Study contactRohit Malhotra · Principal investigatorMore trials in Charlottesville
- Inova Heart and Vascular Institute · Falls Church, VA 22042Tracy Plummer · Study contact · (703) 776-3567 · tracy.plummer@inova.orgBrett Atwater, MD · Principal investigatorMore trials in Falls Church
- Sentara Healthcare · Newport News, VA 23606Linette Klevan · Study contactErich Kiehl · Principal investigatorMore trials in Newport News
- Virginia Commonwealth University · Richmond, VA 23284Melissa Sears · Study contactJordana Kron, MD · Principal investigatorMore trials in Richmond
VT
- University of Vermont · Burlington, VT 05402Sonja Baden · Study contact · (802) 847-8833 · Sonja.Baden@uvmhealth.orgDaniel Lustgarten, MD · Principal investigatorMore trials in Burlington
WA
- University of Washington · Seattle, WA 98195Adele Stefanowicz · Study contact · 0000000000 · amstef99@uw.eduKristen Patton, MD · Principal investigatorMore trials in Seattle