QuickFlex Micro Left Ventricular Lead Post Approval Study
NCT ID: NCT01179477
Last Updated: 2019-08-12
Study Results
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View full resultsBasic Information
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COMPLETED
1930 participants
OBSERVATIONAL
2010-09-30
2017-09-30
Brief Summary
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Detailed Description
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* Freedom from LV lead-related complications at 5 years
* LV bipolar capture threshold of St. Jude Medical's QuickFlex®µ 1258T LV Lead measured at 0.5 ms at 5 years
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Implantation of a QuickFlex® μ Model 1258T LV Lead
Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
Exclusion Criteria
* Have a life expectancy of less than 5 years due to any condition
* Be less than 18 years of age
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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Clay Cohorn
Role: STUDY_DIRECTOR
Abbott Medical Devices
Locations
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Cardiovascular Associates P.C.
Birmingham, Alabama, United States
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Heart Center Research, LLC.
Huntsville, Alabama, United States
Alaska Heart Institute
Anchorage, Alaska, United States
Arizona Arrhythmia Research Center
Phoenix, Arizona, United States
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Arkansas Cardiology
Little Rock, Arkansas, United States
St. Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Northwest Cardiology
Springdale, Arkansas, United States
Glendale Memorial Hospital and Medical Center
Glendale, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Regional Cardiology Associates
Sacramento, California, United States
University of California at San Diego (UCSD) Medical Center
San Diego, California, United States
Claudio Bonometti MD, Inc
Santa Barbara, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA
Torrance, California, United States
Christiana Hospital
Newark, Delaware, United States
Shands Jacksonville
Jacksonville, Florida, United States
Naushad Shaik, MD
Kissimmee, Florida, United States
Munroe Regional Medical Center
Ocala, Florida, United States
Usman R. Siddiqui, MD
Orlando, Florida, United States
Orlando Heart Center
Orlando, Florida, United States
Brevard Cardiovascular Research Associates, Inc.
Rockledge, Florida, United States
University of South Florida, Cardiovascular Services
Tampa, Florida, United States
Athens Regional Medical Center
Athens, Georgia, United States
St. Joseph's Hospital
Atlanta, Georgia, United States
Redmond Regional Medical Center
Rome, Georgia, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
The Heart Group
Newburgh, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Mid-America Cardiology Associates, PC
Kansas City, Kansas, United States
King's Daughters Medical Center
Ashland, Kentucky, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Norton Bluegrass Heart Specialists
Louisville, Kentucky, United States
Peninsula Cardiology Associates, P.A.
Salisbury, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Trinity Health-Michigan d/b/a Michigan Heart
Ann Arbor, Michigan, United States
Thoracic Cardio Healthcare Found. (aka Sparrow Research)
Lansing, Michigan, United States
MidMichigan Physicians Group
Midland, Michigan, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Cardiology Associates of North Mississippi
Tupelo, Mississippi, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Heart Consultants P.C.
Omaha, Nebraska, United States
AtlantiCare Regional Medical Center
Pomona, New Jersey, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
New Jersey Cardiology Associates
West Orange, New Jersey, United States
Lenox Hill Hospital
New York, New York, United States
LeBauer HeartCare
Greensboro, North Carolina, United States
Wake Forest University Medical Center Clinical Sciences
Winston-Salem, North Carolina, United States
Primed Cardiology/Kettering Medical Center Network
Kettering, Ohio, United States
Regional Cardiovascular Medical Center
Steubenville, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Toledo Clinic
Toledo, Ohio, United States
St. Elizabeth Health Center
Youngstown, Ohio, United States
Providence Heart and Vascular Institute
Portland, Oregon, United States
Tri-State Medical Group Cardiology
Beaver, Pennsylvania, United States
Capital Cardiovascular Associates
Camp Hill, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
Sayre, Pennsylvania, United States
WellSpan Health
York, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Cardiology Consultants
Johnson City, Tennessee, United States
Methodist University Hospital
Memphis, Tennessee, United States
The Stern Cardiovascular Foundation
Memphis, Tennessee, United States
Texas Cardiac Arrhythmia
Austin, Texas, United States
HeartPlace
Bedford, Texas, United States
Advanced Heart Care
Plano, Texas, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Cardiovascular Associates of East Texas
Tyler, Texas, United States
McKay-Dee Heart Services
Ogden, Utah, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Cardiovascular Associates Ltd
Chesapeake, Virginia, United States
Charleston Area Medical Center
Charleston, West Virginia, United States
St. Mary's Hospital
Madison, Wisconsin, United States
Cardiac Rhythm Specialists, S.C.
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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CRD561
Identifier Type: -
Identifier Source: org_study_id
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