Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1686 participants
INTERVENTIONAL
2019-10-03
2026-06-30
Brief Summary
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Detailed Description
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For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at biventricular (BiV) pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration.
For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings.
Sites will collect data at baseline (before CRT implant), randomization, and at 3-month, 6-month, and 12-month visits. For subjects randomized to the SyncAV ON arm, sites will optimize the SyncAV feature again at 3 months and 6 months in the same manner as the randomization visit.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SyncAV Arm
Treatment Arm
SyncAV programmed ON
For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at BiV pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration.
Fixed AV Delay Arm
Control Arm
Fixed AV delay
For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings.
Interventions
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SyncAV programmed ON
For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at BiV pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration.
Fixed AV delay
For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings.
Eligibility Criteria
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Inclusion Criteria
1. Mild to severe heart failure despite optimal medical therapy for at least 3 months prior to signing consent. Optimal medical therapy is defined as maximal tolerated dose of beta-blockers and a therapeutic dose of angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or aldosterone antagonist
2. LVEF ≤ 35% based on a prior standard of care echocardiogram
3. Left bundle branch block (LBBB) as documented on an ECG. Criteria for complete LBBB should include,
i. QRS duration ≥ 120 ms ii. QS or rS pattern in leads V1 iii. mid-QRS notching or slurring in leads I, aVL, V5, and V6 iv. Absence of Q-wave in leads V5 and V6 d. Intact AV conduction (PR interval ≤ 280 ms on surface ECG)
2. At least 18 years old, or of legal age and willing and capable to give informed consent specific to each country and national laws
3. Willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria
2. Recent cardiac revascularization (angioplasty, stent or bypass graft) in the 4 weeks prior to signing consent or planned within 3 months following consent
3. Cerebrovascular accident or transient ischemic attack in the 3 months prior to signing consent
4. Any other therapeutic cardiovascular procedure (transcatheter aortic valve replacement, MitraClip, cardiac surgery, left atrial appendage closure, patent foramen ovale closure, or any ablation procedures) in the 3 months prior to signing consent
5. Permanent or persistent AF at the time of signing consent
6. Paroxysmal AF with at least one cardioversion within 60 days prior to signing consent
7. Prior CRT device implant
8. Prior His Bundle pacing implant or plan to have His Bundle pacing implant
9. Pregnant or breastfeeding at the time of signing consent
10. Incapacitated or unable to read or write
11. Undergone cardiac transplantation or have a classification of Status 1 for cardiac transplantation or consideration for transplantation during the study follow-up period
12. Life expectancy \< 12 months due to any condition
13. Unavailable for at least 12 months of follow-up visits
14. Enrolled in or intend to participate in a clinical drug and/or device study during this clinical trial which could confound the results of this trial as determined by Abbott
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Niraj Varma, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Heart Center Research, LLC.
Huntsville, Alabama, United States
Arizona Cardiovascular Research Center
Phoenix, Arizona, United States
HonorHealth
Scottsdale, Arizona, United States
Comprehensive Cardiovascular
Bakersfield, California, United States
Cardiovascular Consultants Heart Center
Fresno, California, United States
USC University Hospital
Los Angeles, California, United States
Colorado Heart & Vascular, P.C.
Lakewood, Colorado, United States
Shands at the University of Florida
Gainesville, Florida, United States
Heart Rhythm Solutions
Hollywood, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Deborah Heart & Lung Center
Browns Mills, New Jersey, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights, New Jersey, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr.
Houston, Texas, United States
Memorial Katy Cardiology Associates
Houston, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Heart Rhythm Associates
Shenandoah, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Universitätsklinik Graz
Graz, Styria, Austria
Hopital Erasme
Brussels, , Belgium
Foothills Medical Centre
Calgary, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Royal Jubilee Hospital
Victoria, British Columbia, Canada
Hopital du Sacre-Coeur de Montreal
Montreal, Montreal, Canada
HSC, Eastern Health
St. John's, Newfoundland and Labrador, Canada
QE II Health Sciences
Halifax, Nova Scotia, Canada
Kingston General Hospital
Kingston, Ontario, Canada
St. Mary's General Hospital
Kitchener, Ontario, Canada
Cardiac Arrhythmia Research Group Inc. (CARGI)
Scarborough Village, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Institut de Cardiologie de Montreal (Montreal Heart Inst.)
Montreal, Quebec, Canada
McGill University Health Centre General Hospital
Montreal, Quebec, Canada
CHUS Fleurimont
Sherbrooke, Quebec, Canada
Royal Alexandra Hospital
Edmonton, , Canada
CHUM
Montreal, , Canada
Institut de Cardiologie de Quebec (Hôpital Laval)
Québec, , Canada
Tianjin Chest Hospital
Tianjin, Heping, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Helsinki University Central Hospital (HYKS)
Helsinki, , Finland
CHU Rangueil Toulouse
Toulouse, Midi-Pyrenees, France
CHRU Hopital de Pontchaillou
Rennes, , France
St-Etienne CHU
Saint-Priest-en-Jarez, , France
Hopital Henri Mondor
Créteil, Île-de-France Region, France
CHR de La Reunion - Site du CHFG
Saint-Denis, Île-de-France Region, France
Klinikum der Ruprecht-Karls-Universität Heidelberg
Heidelberg, Bad-wur, Germany
Herzzentrum Dresden GmbH Universitätsklinik
Dresden, Saxony, Germany
Kerckhoff-Klinik gGmbH
Bad Nauheim, , Germany
The University of Hong Kong (Queen Mary Hospital)
Hong Kong, , Hong Kong
Asian Institute of Gastroenterology (AIG) Hospital
Hyderabad, Andprad, India
Care Institute of Medical Sciences
Ahmedabad, Gujarat, India
Apollo Hospitals, Bangalore
Bangalore, Karnataka, India
Narayana Institute of Cardiac Sciences, Bommasandra
Bangalore, Karnataka, India
Medanta - The Medicity Hospital
Gūrgaon, , India
Max Super Specialty Hospital
New Delhi, , India
Mater Dei Hospital
Bari, Apulia, Italy
Azienda Ospedaliera Di Venere
Carbonara, Apulia, Italy
Azienda Ospedaliera Universitaria MaterDomini
Catanzaro, Calabria, Italy
Azienda Ospedaliera S. G. Moscati
Avellino, , Italy
Chiba University
Chiba, Chiba, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Kanagwa, Japan
Amsterdam Academic Medical Centre (AMC)
Amsterdam, Noord-h, Netherlands
Scanmed SA
Krakow, Lesrpld, Poland
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
Poznan, , Poland
Santa Maria Hospital
Lisbon, , Portugal
Arrhythmia Group LLC
Ponce, , Puerto Rico
Meshalkin National Medical Research Center
Novosibirsk, Siberia, Russia
King Fahad Armed Forces Hospital
Jeddah, Mecca Region, Saudi Arabia
King Faisal Specialist Hospital (KFSH)
Riyadh, Riyadh Region, Saudi Arabia
King Fahad Medical City
Riyadh, , Saudi Arabia
Clinical Center of Serbia - Pacemaker Center
Belgrade, , Serbia
Sejong Hospital
Bucheon-si, Sudogwn, South Korea
Keimyung University Dongsan Medical Center
Daegu, Sudogwn, South Korea
Seoul National University Bundang Hospital
Seongnam, Sudogwn, South Korea
Samsung Medical Center
Seoul, Sudogwon, South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Asan Medical Centre
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Universitario Infanta Cristina
Badajoz, , Spain
Hospital Clínic de Barcelona
Barcelona, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Puerta de Hierro - Hospital Universitario
Madrid, , Spain
HCU Virgen de la Victoria
Málaga, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Karolinska University Hospital, Solna
Stockholm, , Sweden
Taichung Veterans General Hospital
Taichung, , Taiwan
Phramongkutklao Hospital
Bangkok, Central Thailand, Thailand
Southampton University Hospital
Southampton, Soeast, United Kingdom
John Radcliffe Hospital
Oxford, South East England, United Kingdom
The Royal Sussex County Hospital
Brighton, , United Kingdom
Countries
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Other Identifiers
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ABT-CIP-10299
Identifier Type: -
Identifier Source: org_study_id