Advance Cardiac Resynchronization Therapy (CRT) Registry
NCT ID: NCT01805154
Last Updated: 2019-08-12
Study Results
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View full resultsBasic Information
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COMPLETED
1529 participants
OBSERVATIONAL
2013-01-31
2017-09-30
Brief Summary
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Detailed Description
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During the office follow-up visits, arrhythmic episode diagnoses, device data and stored electrogram will be collected. All clinical events such as hospitalization for heart failure (HF), all-cause hospitalizations, and all-cause death will also be collected. For patients who are non-responders to CRT, any re-optimization of the device, i.e., atrioventricular and ventricle-to-ventricle interval optimization, left ventricular (LV) lead repositioning and pacing vector reconfiguration as well as modified/new clinical therapies administered in an attempt to improve HF condition will be collected.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CRT patients
Patients who have received any market approved St Jude Medical CRT-D or CRT-P device
CRT Patients
This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.
Interventions
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CRT Patients
This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients implanted with any market-approved St. Jude Medical CRT-D/P device with no prior LV lead placement
Exclusion Criteria
* Are less than 18 years of age
* Are pregnant or planning to become pregnant during the duration of the study
* Are currently participating in a clinical investigation that includes an active treatment arm
* Have a life expectancy of less than 6 months
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: STUDY_CHAIR
The Cleveland Clinic
Locations
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Alabama Cardiovascular Group, P.C.
Birmingham, Alabama, United States
*Heart Center Research, LLC.
Huntsville, Alabama, United States
Cardiovascular Consultants Ltd
Glendale, Arizona, United States
Cardiovascular Associates of Mesa
Mesa, Arizona, United States
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States
Southern Arizona VA Health Care System
Tucson, Arizona, United States
Comprehensive Cardiovascular
Bakersfield, California, United States
Chula Vista Cardiac Center
Chula Vista, California, United States
Cardiac Rhythm Specialist
Northridge, California, United States
Claudio Bonometti MD, Inc
Santa Barbara, California, United States
The Cardiac & Vascular Institute Research Foundation, LLC
Gainesville, Florida, United States
Cardiology Consultants - Baptist Campus
Pensacola, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
VA Medical Center - Tampa
Tampa, Florida, United States
Heartland Cardiovascular Center
Joliet, Illinois, United States
Advocate Health and Hospitals Corporation
Oakbrook Terrace, Illinois, United States
Unitypoint
Des Moines, Iowa, United States
Heart Care Associates PSC
Madisonville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Cardiology Consultants of East Michigan
Flint, Michigan, United States
*Thoracic Cardio Healthcare Found. (aka Sparrow Research)
Lansing, Michigan, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
St. Louis University Hospital
St Louis, Missouri, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Lourdes Cardiology Services
Cherry Hill, New Jersey, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Genesis HealthCare System
Zanesville, Ohio, United States
Saint Vincent Consultants in Cardiovascular Diseases
Erie, Pennsylvania, United States
Mountain States Medical Group Cardiology
Johnson City, Tennessee, United States
Knoxville Cardiovascular Research Group, LLC
Knoxville, Tennessee, United States
Texas Cardiac Arrhythmia
Austin, Texas, United States
North Texas Heart Center
Dallas, Texas, United States
Martha Jefferson
Charlottesville, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
Cardiac Rhythm Specialists, S.C.
Milwaukee, Wisconsin, United States
Cheyenne Cardiology Associates
Cheyenne, Wyoming, United States
Fundacion Favaloro para la Docencia e Inv. med.
Buenos Aires, Riodepl, Argentina
Instituto Cardiovascular Buenos Aires (ICBA)
Buenos Aires, Riodepl, Argentina
Biocor Instituto
Nova Lima, Minas Gerais, Brazil
Hospital Beneficiencia Portuguesa de Sao Paulo
São Paulo, Sao Pau, Brazil
Instituto do Coracao (InCor) - HCFMUSP
São Paulo, , Brazil
Anhui Provincial Hospital
Hefei, Anhui, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The 2nd Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
APEX Foundation
Medellín, Antioq, Colombia
Care Institute of Medical Sciences
Ahmedabad, Gujarat, India
Holy Family Hospital and Medical Research Center
Mumbai, Mhrshtr, India
Ruby Hall Clinic
Pune, Mhrshtr, India
Delhi Heart and Lung Institute
New Delhi, National Capital Territory of Delhi, India
Escorts Heart Institute and Research Centre
New Delhi, National Capital Territory of Delhi, India
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi, India
Medanta - The Medicity Hospital
Gurgaon, NCT DLH, India
Fortis Escorts Hospital
Amritsar, Punjab, India
Fortis Hospital
Mohali, Punjab, India
The Madras Medical Mission
Chennai, Tmlnadu, India
Fujita Health University School of medicine
Toyoake, Aichi-ken, Japan
Hirosaki University Hospital
Hirosaki-shi, Aomori, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Chiba University
Chiba, , Japan
Heart Rhythm Management
San Juan, , Puerto Rico
Eulji university Hospital Daejeon
Daejeon, Hoseo, South Korea
Samsung Medical Center
Seoul, Sudogwn, South Korea
Yonsei University Health System
Seoul, Sudogwn, South Korea
Countries
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References
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Varma N, Wang JA, Jaswal A, Sethi KK, Kondo Y, Joung B, Yoo D, Auricchio A, Singh JP, Lee K, Gold MR. CRT Efficacy in "Mid-Range" QRS Duration Among Asians Contrasted to Non-Asians, and Influence of Height. JACC Clin Electrophysiol. 2022 Feb;8(2):211-221. doi: 10.1016/j.jacep.2021.09.012. Epub 2021 Nov 24.
Varma N, Boehmer J, Bhargava K, Yoo D, Leonelli F, Costanzo M, Saxena A, Sun L, Gold MR, Singh J, Gill J, Auricchio A. Evaluation, Management, and Outcomes of Patients Poorly Responsive to Cardiac Resynchronization Device Therapy. J Am Coll Cardiol. 2019 Nov 26;74(21):2588-2603. doi: 10.1016/j.jacc.2019.09.043.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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60046199
Identifier Type: -
Identifier Source: org_study_id
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