Phase
Condition
Chest Pain
Hyponatremia
Circulation Disorders
Treatment
His/LBBP
BiVP
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 toenrollment OR anticipated right ventricular pacing >40% OR device in place withright ventricular pacing > 40%.
Are optimized on HF guideline directed medical therapy according to current HFpublished guidelines OR patient's physician will make an effort to start allguideline-directed medical therapy and titrate doses up as permitted by theparticipant clinical status and co-morbidities prior to implantation procedure.
Exclusion
Exclusion Criteria:
Women who are pregnant, lactating, or plan to become pregnant during the course ofthe trial.
Participants with angiographic evidence of coronary disease who are candidates forcoronary revascularization and are likely to undergo coronary artery bypass graftsurgery or percutaneous coronary, intervention in the next three (3) months.
Enzyme-positive myocardial infarction within the past three (3) months prior toenrollment.
Coronary artery bypass graft surgery or percutaneous coronary intervention (balloonand/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 6months.
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 pretreatmentwith steroids and/or diphenhydramine.
Participants participating in any other interventional cardiovascular clinicaltrial.
Participants who would be unable to comply with the study's follow-up visitschedule; or
Participants who had any prior unsuccessful attempt at implantation of biventricularpacing (BiVP), His Bundle Pacing (HBP), or Left Bundle Branch Pacing (LBBP) device.
Study Design
Study Description
Connect with a study center
Mazankowski Alberta Heart Institute/University of Alberta
Edmonton 5946768, Alberta 5883102
CanadaSite Not Available
University of British Columbia
Vancouver 6173331, British Columbia 5909050
CanadaActive - Recruiting
Victoria Cardiac Arrhythmia Trials (VCAT) Inc.
Victoria 6174041, British Columbia 5909050
CanadaActive - Recruiting
Nova Scotia Health Authority
Halifax 6324729, Nova Scotia 6091530
CanadaActive - Recruiting
Hamilton Health Sciences (HHS)
Hamilton 5969782, Ontario 6093943
CanadaActive - Recruiting
Newmarket Electrophysiology Research Group Inc. (NERG)
Newmarket 6087701, Ontario 6093943
CanadaActive - Recruiting
University of Ottawa Heart Institute
Ottawa 6094817, Ontario 6093943
CanadaActive - Recruiting
Sunnybrook Research Institute
Toronto 6167865, Ontario 6093943
CanadaActive - Recruiting
Montreal Heart Institute
Montreal 6077243, Quebec 6115047
CanadaActive - Recruiting
CIUSSS de l'Estrie - CHUS
Saint-Jean-sur-Richelieu 6138495, Quebec 6115047
CanadaSite Not Available
University of Calgary
Calgary,
CanadaSite Not Available
University of Calgary
Calgary 5913490,
CanadaActive - Recruiting
Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital
Kitchener,
CanadaSite Not Available
Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital
Kitchener 5992996,
CanadaActive - Recruiting
Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital
Montreal 6077243,
CanadaActive - Recruiting
Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital
Montréal,
CanadaSite Not Available
Université Laval
Québec 6325494,
CanadaActive - Recruiting
Mercy Gilbert & Chandler Regional Medical Centers, Gilbert AZ
Gilbert 5295903, Arizona 5551752 85297
United StatesActive - Recruiting
University of Arizona College of Medicine- Phoenix
Tucson 5318313, Arizona 5551752 85719
United StatesActive - Recruiting
University of Arkansas for Medical Sciences (UAMS)
Little Rock 4119403, Arkansas 4099753 72205
United StatesActive - Recruiting
University of California San Diego
La Jolla 5363943, California 5332921 92093
United StatesActive - Recruiting
University of Colorado (Anschutz Medical Campus)
Denver 5419384, Colorado 5417618 80217
United StatesActive - Recruiting
South Denver Cardiology Associates
Littleton 5429032, Colorado 5417618 80124
United StatesActive - Recruiting
Hartford Hospital
Hartford 4835797, Connecticut 4831725 06102
United StatesActive - Recruiting
Yale University
New Haven 4839366, Connecticut 4831725 06511
United StatesActive - Recruiting
Heart Rhythm Solutions
Davie 4152820, Florida 4155751 33328
United StatesActive - Recruiting
University of Florida Jacksonville
Jacksonville 4160021, Florida 4155751 32211
United StatesSite Not Available
Mount Sinai Medical Center of Florida, Inc.
Miami Beach 4164143, Florida 4155751 33140
United StatesSite Not Available
Cleveland Clinic Florida
Palm Beach Gardens 4167519, Florida 4155751 33418
United StatesActive - Recruiting
Florida Heart and Vascular, LLC dba Florida Heart Rhythm Specialist, PLLC
South Pasadena 4173524, Florida 4155751 33707
United StatesSite Not Available
University of South Florida
Tampa 4174757, Florida 4155751 33613
United StatesActive - Recruiting
Rush University
Chicago, Illinois 60612
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Rush University
Chicago 4887398, Illinois 4896861 60612
United StatesActive - Recruiting
University of Chicago
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
Northwestern University
Evanston 4891382, Illinois 4896861 60208
United StatesActive - Recruiting
CIS Clinical Research Corporation
Naperville 4903279, Illinois 4896861 60540
United StatesSite Not Available
Trustees of Indiana University
Indianapolis 4259418, Indiana 4921868 46202
United StatesActive - Recruiting
Baptist Health Louisville
Louisville 4299276, Kentucky 6254925 40207
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
HMH Hospitals Corporation
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Virtua Health
Marlton 4502911, New Jersey 5101760 08053
United StatesActive - Recruiting
Newark Beth Israel Medical Center
Newark 5101798, New Jersey 5101760 07112
United StatesActive - Recruiting
The Valley Hospital, Inc.
Ridgewood 5103269, New Jersey 5101760 07450
United StatesActive - Recruiting
Lovelace Medical Center
Albuquerque, New Mexico 87102
United StatesSite Not Available
Lovelace Medical Center
Albuquerque 5454711, New Mexico 5481136 87102
United StatesActive - Recruiting
Columbia University Irving Medical Center
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Columbia University Medical Center/New York-Presbyterian Hospital (CUMC/NYPH)
New York 5128581, New York 5128638 10032
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
United StatesActive - Recruiting
Weill Cornell Medicine
New York 5128581, New York 5128638 10021
United StatesActive - Recruiting
Novant Health
Charlotte, North Carolina 28204
United StatesSite Not Available
MH Mission Hospital LLLP- Asheville Cardiology Associates
Asheville 4453066, North Carolina 4482348 28803
United StatesActive - Recruiting
University of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27599
United StatesActive - Recruiting
Novant Health
Charlotte 4460243, North Carolina 4482348 28204
United StatesActive - Recruiting
The Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219
United StatesActive - Recruiting
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
The MetroHealth System
Cleveland 5150529, Ohio 5165418 44109
United StatesActive - Recruiting
Oregon Health & Science University
Portland 5746545, Oregon 5744337 97239
United StatesActive - Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Geisinger Commonwealth School of Medicine
Scranton, Pennsylvania 18510
United StatesSite Not Available
Lehigh Valley Hospital Inc.
Allentown 5178127, Pennsylvania 6254927 18103
United StatesActive - Recruiting
St. Luke's University Health Network
Allentown 5178127, Pennsylvania 6254927 18015
United StatesActive - Recruiting
Penn Medicine Lancaster General
Lancaster 5197079, Pennsylvania 6254927 17603
United StatesActive - Recruiting
Thomas Jefferson University Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesActive - Recruiting
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
United StatesActive - Recruiting
Allegheny-Singer Research Institute
Pittsburgh 5206379, Pennsylvania 6254927 15212
United StatesActive - Recruiting
University of Pittsburg
Pittsburgh 5206379, Pennsylvania 6254927 15213
United StatesActive - Recruiting
Geisinger Commonwealth School of Medicine
Scranton 5211303, Pennsylvania 6254927 18510
United StatesActive - Recruiting
Medical University of South Carolina (MUSC)
Charleston 4574324, South Carolina 4597040 29425
United StatesActive - Recruiting
Prisma Health-Upstate
Greenville 4580543, South Carolina 4597040 29605
United StatesSite Not Available
Texas Health Research & Education Institute
Arlington 4671240, Texas 4736286 76011
United StatesSite Not Available
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
St. Mark's Hospital
Salt Lake City 5780993, Utah 5549030 84124
United StatesActive - Recruiting
University of Vermont
Burlington 5234372, Vermont 5242283 05402
United StatesActive - Recruiting
University of Virginia Health System
Charlottesville, Virginia 22908
United StatesSite Not Available
Sentara Healthcare
Newport News, Virginia 23606
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23284
United StatesSite Not Available
University of Virginia Health System
Charlottesville 4752031, Virginia 6254928 22908
United StatesActive - Recruiting
Inova Heart and Vascular Institute
Falls Church 4758390, Virginia 6254928 22042
United StatesActive - Recruiting
Sentara Healthcare
Newport News 4776024, Virginia 6254928 23606
United StatesActive - Recruiting
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23284
United StatesActive - Recruiting
University of Washington
Seattle 5809844, Washington 5815135 98195
United StatesActive - Recruiting

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