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
- Diseases
- Heart failure
- 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
Sites (71)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Calgary Coordinator of this site? Confirm its status | Calgary | Canada | Recruiting |
| Mazankowski Alberta Heart Institute/University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Not yet recruiting |
| Nova Scotia Health Authority Coordinator of this site? Confirm its status | Halifax | Canada | Recruiting |
| Hamilton Health Sciences (HHS) Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital Coordinator of this site? Confirm its status | Kitchener | Canada | Recruiting |
| Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Montreal Heart Institute Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Newmarket Electrophysiology Research Group Inc. (NERG) Coordinator of this site? Confirm its status | Newmarket | Canada | Recruiting |
| University of Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| CIUSSS de l'Estrie - CHUS Coordinator of this site? Confirm its status | Saint-Jean-sur-Richelieu | Canada | Not yet recruiting |
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| University of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
| Victoria Cardiac Arrhythmia Trials (VCAT) Inc. Coordinator of this site? Confirm its status | Victoria | Canada | Recruiting |
| Lovelace Medical Center Coordinator of this site? Confirm its status | Albuquerque | United States | Recruiting |
| St. Luke's University Health Network Coordinator of this site? Confirm its status | Allentown | United States | Recruiting |
| Lehigh Valley Hospital, Inc Coordinator of this site? Confirm its status | Allentown | United States | Recruiting |
| Texas Health Research & Education Institute Coordinator of this site? Confirm its status | Arlington | United States | Not yet recruiting |
| MH Mission Hospital LLLP- Asheville Cardiology Associates Coordinator of this site? Confirm its status | Asheville | United States | Recruiting |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Vermont Coordinator of this site? Confirm its status | Burlington | United States | Recruiting |
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
| Medical University of South Carolina (MUSC) Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Novant Health Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| University of Virginia Health System Coordinator of this site? Confirm its status | Charlottesville | United States | Recruiting |
| RUSH University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| The Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Recruiting |
| The MetroHealth System Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Heart Rhythm Solutions Coordinator of this site? Confirm its status | Davie | United States | Recruiting |
| University of Colorado (Anschutz Medical Campus) Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Evanston | United States | Recruiting |
| Inova Heart and Vascular Institute Coordinator of this site? Confirm its status | Falls Church | United States | Recruiting |
| Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ Coordinator of this site? Confirm its status | Gilbert | United States | Recruiting |
| Prisma Health-Upstate Coordinator of this site? Confirm its status | Greenville | United States | Not yet recruiting |
| HMH Hospitals Corporation Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| Hartford Hospital Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Trustees of Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Recruiting |
| University of Florida - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Not yet recruiting |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Penn Medicine Lancaster General Coordinator of this site? Confirm its status | Lancaster | United States | Recruiting |
| University of Arkansas for Medical Sciences (UAMS) Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| South Denver Cardiology Associates Coordinator of this site? Confirm its status | Littleton | United States | Recruiting |
| Baptist Health Louisville Coordinator of this site? Confirm its status | Louisville | United States | Recruiting |
| Virtua Health Coordinator of this site? Confirm its status | Marlton | United States | Recruiting |
| Mount Sinai Medical Center of Florida, Inc. Coordinator of this site? Confirm its status | Miami Beach | United States | Not yet recruiting |
| CIS Clinical Research Corporation Coordinator of this site? Confirm its status | Naperville | United States | Enrolling by invitation |
| Newark Beth Israel Medical Center Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Sentara Healthcare Coordinator of this site? Confirm its status | Newport News | United States | Recruiting |
| Weill Cornell Medicine Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH) Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Cleveland Clinic Florida Coordinator of this site? Confirm its status | Palm Beach Gardens | United States | Recruiting |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| University of Pittsburg Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Allegheny-Singer Research Institute Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| The Valley Hospital Inc. Coordinator of this site? Confirm its status | Ridgewood | United States | Recruiting |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| St. Mark's Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Geisinger Commonwealth School of Medicine Coordinator of this site? Confirm its status | Scranton | United States | Recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC Coordinator of this site? Confirm its status | South Pasadena | United States | Not yet recruiting |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| University of Arizona College of Medicine- Phoenix Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.