Study Results
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View full resultsBasic Information
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COMPLETED
2216 participants
OBSERVATIONAL
2013-03-31
2019-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with SJM leads implanted
Patient has at least one market released Riata, Riata ST, QuickSite/QuickFlex, or Durata lead implanted
Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads
Riata leads implanted between 2002-2009 Riata ST leads implanted between 2006-2009 Quicksite or QuickFlex leads implanted between 2006-2010 Durata leads implanted between 2008-2010
Subjects were followed for three years and cinefluoroscopy imaging was done annually to determine prevalence of externalized conductors or other visual lead anomalies
Interventions
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Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads
Riata leads implanted between 2002-2009 Riata ST leads implanted between 2006-2009 Quicksite or QuickFlex leads implanted between 2006-2010 Durata leads implanted between 2008-2010
Subjects were followed for three years and cinefluoroscopy imaging was done annually to determine prevalence of externalized conductors or other visual lead anomalies
Eligibility Criteria
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Inclusion Criteria
2. Patient has at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted in which the lead model number and lead implant date is indicated in Table 1 (see protocol attached.)
3. Have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in this study plan.
4. Are 18 years or above
Exclusion Criteria
2. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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Cardiology, P.C.
Birmingham, Alabama, United States
University Hospital of Alabama at Birmingham
Birmingham, Alabama, United States
Heart Center Research
Huntsville, Alabama, United States
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Scripps Green Hospital
La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Cardiac Rhythm Specialists
Reseda, California, United States
Mercy Medical Group
Sacramento, California, United States
St. Joseph's Medical Center
Stockton, California, United States
Penrose St. Francis Health Services
Colorado Springs, Colorado, United States
Naples Heart Rhytm Specialists, PA
Naples, Florida, United States
Redmond Regional Medical Center
Rome, Georgia, United States
OSF Healthcare Cardiovascular Institute
Peoria, Illinois, United States
Mid-America Cardiology Associates, PC
Kansas City, Kansas, United States
Heart Clinic of Hammond, LLC
Hammond, Louisiana, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Sparrow Clinical Research Institute
Lansing, Michigan, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
Methodist Physicians Clinic-Heart Consultants
Omaha, Nebraska, United States
Deborah Heart and Lung
Browns Mills, New Jersey, United States
New Mexico Heart Institute
Albuquerque, New Mexico, United States
Asheville Cardiology Associates
Asheville, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Providence Heart & Vascular Institute
Portland, Oregon, United States
Saint Vincent Consultants in Cardiovascular Diseases
Erie, Pennsylvania, United States
Drexel University College oF Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States
Wellspan Health
York, Pennsylvania, United States
Sutherland Cardiology Clinic
Germantown, Tennessee, United States
Mountain States Medical Group Cardiology
Johnson City, Tennessee, United States
Arrhythmia Consultants
Memphis, Tennessee, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Aurora Medical Group
Milwaukee, Wisconsin, United States
QE II Health Sciences
Halifax, Nova Scotia, Canada
University of Tsukuba Hospital
Tsukuba, Ibaraki, Japan
Osaka City University Hospital
Osaka, Osaka, Japan
Kyoto-Katsura Hospital
Kyoto, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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CRD-619
Identifier Type: OTHER
Identifier Source: secondary_id
60039775/K
Identifier Type: -
Identifier Source: org_study_id
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