Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study
NCT ID: NCT00990665
Last Updated: 2019-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
NA
178 participants
INTERVENTIONAL
2009-09-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CRT-D and LV lead
CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
Promote Q CRT-D and Quartet LV lead
Interventions
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CRT-D and LV lead (Quartet™ lead and Promote Q® device system)
Promote Q CRT-D and Quartet LV lead
Eligibility Criteria
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Inclusion Criteria
* Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement.
* Ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria
* Have a contraindication for an emergency thoracotomy
* Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
* Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
* Have undergone a cardiac transplantation within 40 days of enrollment
* Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment
* Are currently participating in a clinical investigation that includes an active treatment arm
* Are pregnant or planning to become pregnant during the duration of the study
* Have a life expectancy of less than 6 months due to any condition
* Are less than 18 years of age
* Are unable to comply with the follow up schedule
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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Gery Tomassoni, MD
Role: STUDY_CHAIR
Central Baptist Hospital
Locations
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University Hospital of Alabama at Birmingham
Birmingham, Alabama, United States
Baptist Health Medical Center
Little Rock, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Glendale Memorial Medical Center
Glendale, California, United States
University of Southern California
Los Angeles, California, United States
ACS Research Group
Mountain View, California, United States
Regional Cardiology Associates
Sacramento, California, United States
Scripps Green Hospital
San Diego, California, United States
Orlando Heart Center
Orlando, Florida, United States
The Heart and Vascular Institute of Florida - S. Pinellas
St. Petersburg, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Midwest Heart Foundation
Lombard, Illinois, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Lahey Clinical Medical Center
Burlington, Massachusetts, United States
Thoracic Cardiovascular Healthcare Foundation
Lansing, Michigan, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, United States
Morristown Memorial Hospital
Morristown, New Jersey, United States
Mount Sinai Hospital
New York, New York, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
EMH Regional Medical Center
Elyria, Ohio, United States
Lancaster Heart Foundation
Lancaster, Pennsylvania, United States
Methodist University Hospital
Memphis, Tennessee, United States
St. Thomas Hospital
Nashville, Tennessee, United States
Arrhythmia Center for Southern Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Tomassoni G, Baker J, Corbisiero R, Love C, Martin D, Niazi I, Sheppard R, Worley S, Beau S, Greer GS, Aryana A, Cao M, Harbert N, Zhang S; Promote(R) Q CRT-D and Quartet(R) Left Ventricular Heart Lead Study Group. Postoperative performance of the Quartet(R) left ventricular heart lead. J Cardiovasc Electrophysiol. 2013 Apr;24(4):449-56. doi: 10.1111/jce.12065. Epub 2013 Jan 22.
Other Identifiers
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60024498/E
Identifier Type: -
Identifier Source: org_study_id
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