Left vs Left Randomized Clinical Trial

NARecruitingINTERVENTIONAL
Enrollment

2,136

Participants

Timeline

Start Date

September 13, 2023

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2029

Conditions
Heart FailureHeart Failure With Reduced Ejection FractionAV BlockLBBBRBBBIntraventricular Conduction DelayPacing-Induced Cardiomyopathy
Interventions
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%.

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."

Trial Locations (71)

10021

RECRUITING

Weill Cornell Medicine, New York

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

10032

NOT_YET_RECRUITING

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

15212

RECRUITING

Allegheny-Singer Research Institute, Pittsburgh

15213

RECRUITING

University of Pittsburg, Pittsburgh

17603

RECRUITING

Penn Medicine Lancaster General, Lancaster

18015

RECRUITING

St. Luke's University Health Network, Allentown

18103

RECRUITING

Lehigh Valley Hospital Inc., Allentown

18510

RECRUITING

Geisinger Commonwealth School of Medicine, Scranton

19104

RECRUITING

University of Pennsylvania, Philadelphia

19107

RECRUITING

Thomas Jefferson University Hospital, Philadelphia

22042

RECRUITING

Inova Heart and Vascular Institute, Falls Church

22908

RECRUITING

University of Virginia Health System, Charlottesville

23284

RECRUITING

Virginia Commonwealth University, Richmond

23606

RECRUITING

Sentara Healthcare, Newport News

27599

RECRUITING

University of North Carolina, Chapel Hill

28204

RECRUITING

Novant Health, Charlotte

28803

RECRUITING

MH Mission Hospital LLLP- Asheville Cardiology Associates, Asheville

29425

RECRUITING

Medical University of South Carolina (MUSC), Charleston

29605

NOT_YET_RECRUITING

Prisma Health-Upstate, Greenville

32211

NOT_YET_RECRUITING

University of Florida Jacksonville, Jacksonville

33140

NOT_YET_RECRUITING

Mount Sinai Medical Center of Florida, Inc., Miami Beach

33328

RECRUITING

Heart Rhythm Solutions, Davie

33418

RECRUITING

Cleveland Clinic Florida, Palm Beach Gardens

33613

RECRUITING

University of South Florida, Tampa

33707

NOT_YET_RECRUITING

Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC, South Pasadena

40207

RECRUITING

Baptist Health Louisville, Louisville

44109

RECRUITING

The MetroHealth System, Cleveland

44195

RECRUITING

Cleveland Clinic, Cleveland

45219

RECRUITING

The Christ Hospital, Cincinnati

46202

RECRUITING

Trustees of Indiana University, Indianapolis

55905

RECRUITING

Mayo Clinic, Rochester

60208

RECRUITING

Northwestern University, Evanston

60540

ENROLLING_BY_INVITATION

CIS Clinical Research Corporation, Naperville

60612

RECRUITING

Rush University, Chicago

60637

RECRUITING

University of Chicago, Chicago

72205

RECRUITING

University of Arkansas for Medical Sciences (UAMS), Little Rock

76011

NOT_YET_RECRUITING

Texas Health Research & Education Institute, Arlington

77030

RECRUITING

Baylor College of Medicine, Houston

80124

RECRUITING

South Denver Cardiology Associates, Littleton

80217

RECRUITING

University of Colorado (Anschutz Medical Campus), Denver

84124

RECRUITING

St. Mark's Hospital, Salt Lake City

85297

RECRUITING

Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ, Gilbert

85719

RECRUITING

University of Arizona College of Medicine- Phoenix, Tucson

87102

RECRUITING

Lovelace Medical Center, Albuquerque

92093

RECRUITING

University of California San Diego, La Jolla

97239

RECRUITING

Oregon Health & Science University, Portland

98195

RECRUITING

University of Washington, Seattle

06102

RECRUITING

Hartford Hospital, Hartford

06511

RECRUITING

Yale University, New Haven

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

07601

RECRUITING

HMH Hospitals Corporation, Hackensack

08053

RECRUITING

Virtua Health, Marlton

07112

RECRUITING

Newark Beth Israel Medical Center, Newark

07450

RECRUITING

The Valley Hospital, Inc., Ridgewood

05402

RECRUITING

University of Vermont, Burlington

Unknown

NOT_YET_RECRUITING

Mazankowski Alberta Heart Institute/University of Alberta, Edmonton

RECRUITING

University of British Columbia, Vancouver

RECRUITING

Victoria Cardiac Arrhythmia Trials (VCAT) Inc., Victoria

RECRUITING

Nova Scotia Health Authority, Halifax

RECRUITING

Hamilton Health Sciences (HHS), Hamilton

RECRUITING

Newmarket Electrophysiology Research Group Inc. (NERG), Newmarket

RECRUITING

University of Ottawa Heart Institute, Ottawa

RECRUITING

Sunnybrook Research Institute, Toronto

RECRUITING

Montreal Heart Institute, Montreal

NOT_YET_RECRUITING

CIUSSS de l'Estrie - CHUS, Saint-Jean-sur-Richelieu

RECRUITING

University of Calgary, Calgary

RECRUITING

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

RECRUITING

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

RECRUITING

Université Laval, Québec

All Listed Sponsors
collaborator

Patient-Centered Outcomes Research Institute

OTHER

collaborator

University of Utah

OTHER

collaborator

Virginia Commonwealth University

OTHER

collaborator

Cleveland Clinic Florida

OTHER

collaborator

East Carolina University

OTHER

lead

Baylor College of Medicine

OTHER