Phase
Condition
Congestive Heart Failure
Chest Pain
Heart Failure
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
University of Calgary
Calgary,
CanadaActive - Recruiting
Waterloo Wellington Cardiovascular Research Institute (WWCRI) - St. Mary's General Hospital
Kitchener,
CanadaActive - Recruiting
Research Institute of the McGill University Health Centre (RI-MUHC) - MUHC, Montreal General Hospital
Montréal,
CanadaActive - Recruiting
Rush University
Chicago, Illinois 60612
United StatesActive - Recruiting
University of Chicago
Chicago, Illinois 60637
United StatesActive - Recruiting
Lovelace Medical Center
Albuquerque, New Mexico 87102
United StatesActive - Recruiting
Novant Health
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesActive - Recruiting
Geisinger Commonwealth School of Medicine
Scranton, Pennsylvania 18510
United StatesActive - Recruiting
University of Virginia Health System
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Sentara Healthcare
Newport News, Virginia 23606
United StatesActive - Recruiting
Virginia Commonwealth University
Richmond, Virginia 23284
United StatesActive - Recruiting
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