Heart Failure Clinical Trial

Clinical Trial Finder Heart Failure Trials

QuickFlex Micro Left Ventricular Lead Post Approval Study

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Summary

The purpose of this multicenter post-approval study is to evaluate the acute and chronic performance of the QuickFlex® μ 1258T left ventricular (LV) lead.

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Full Description

The primary endpoints of the study are:

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have an approved indication per American College of Cardiology/American Heart Association/Heart Rhythm Society guidelines for implantation of a CRT-D system or participated in the QuickFlex® μ1258T (Investigational Device Exemption (IDE) study
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 hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
Have a life expectancy of less than 5 years due to any condition
Be less than 18 years of age

Study is for people with:

Heart Failure

Estimated Enrollment:

1930

Study ID:

NCT01179477

Recruitment Status:

Completed

Sponsor:

Abbott Medical Devices

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There are 76 Locations for this study

See Locations Near You

Cardiovascular Associates P.C.
Birmingham Alabama, 35213, United States
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham Alabama, 35294, United States
Heart Center Research, LLC.
Huntsville Alabama, 35801, United States
Alaska Heart Institute
Anchorage Alaska, 99508, United States
Arizona Arrhythmia Research Center
Phoenix Arizona, 85013, United States
Arizona Arrhythmia Consultants
Scottsdale Arizona, 85252, United States
Arkansas Cardiology
Little Rock Arkansas, 72205, United States
St. Vincent Heart Clinic Arkansas
Little Rock Arkansas, 72205, United States
Arkansas Heart Hospital
Little Rock Arkansas, 72211, United States
Northwest Cardiology
Springdale Arkansas, 72764, United States
Glendale Memorial Hospital and Medical Center
Glendale California, 91206, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles California, 90027, United States
Regional Cardiology Associates
Sacramento California, 95819, United States
University of California at San Diego (UCSD) Medical Center
San Diego California, 92118, United States
Claudio Bonometti MD, Inc
Santa Barbara California, 93105, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA
Torrance California, 90502, United States
Christiana Hospital
Newark Delaware, 19713, United States
Shands Jacksonville
Jacksonville Florida, 32209, United States
Naushad Shaik, MD
Kissimmee Florida, 32804, United States
Munroe Regional Medical Center
Ocala Florida, 34471, United States
Usman R. Siddiqui, MD
Orlando Florida, 32803, United States
Orlando Heart Center
Orlando Florida, 32806, United States
Brevard Cardiovascular Research Associates, Inc.
Rockledge Florida, 32955, United States
University of South Florida, Cardiovascular Services
Tampa Florida, 33606, United States
Athens Regional Medical Center
Athens Georgia, 30306, United States
St. Joseph's Hospital
Atlanta Georgia, 30045, United States
Redmond Regional Medical Center
Rome Georgia, 30165, United States
Prairie Education and Research Cooperative
Springfield Illinois, 62701, United States
Parkview Research Center
Fort Wayne Indiana, 46805, United States
The Heart Group
Newburgh Indiana, 47630, United States
Iowa Heart Center
West Des Moines Iowa, 50266, United States
Mid-America Cardiology Associates, PC
Kansas City Kansas, 66160, United States
King's Daughters Medical Center
Ashland Kentucky, 41101, United States
Central Baptist Hospital
Lexington Kentucky, 40503, United States
Norton Bluegrass Heart Specialists
Louisville Kentucky, 40217, United States
Peninsula Cardiology Associates, P.A.
Salisbury Maryland, 21804, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Trinity Health-Michigan d/b/a Michigan Heart
Ann Arbor Michigan, 48197, United States
Thoracic Cardio Healthcare Found. (aka Sparrow Research)
Lansing Michigan, 48912, United States
MidMichigan Physicians Group
Midland Michigan, 48640, United States
Jackson Heart Clinic
Jackson Mississippi, 39216, United States
Cardiology Associates of North Mississippi
Tupelo Mississippi, 38801, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
Heart Consultants P.C.
Omaha Nebraska, 68122, United States
AtlantiCare Regional Medical Center
Pomona New Jersey, 08240, United States
Lourdes Cardiology Services
Voorhees New Jersey, 08043, United States
New Jersey Cardiology Associates
West Orange New Jersey, 07052, United States
Lenox Hill Hospital
New York New York, 10028, United States
LeBauer HeartCare
Greensboro North Carolina, 27401, United States
Wake Forest University Medical Center Clinical Sciences
Winston-Salem North Carolina, 27157, United States
Primed Cardiology/Kettering Medical Center Network
Kettering Ohio, 45429, United States
Regional Cardiovascular Medical Center
Steubenville Ohio, 43953, United States
The Toledo Hospital
Toledo Ohio, 43615, United States
Toledo Clinic
Toledo Ohio, 43623, United States
St. Elizabeth Health Center
Youngstown Ohio, 44505, United States
Providence Heart and Vascular Institute
Portland Oregon, 97220, United States
Tri-State Medical Group Cardiology
Beaver Pennsylvania, 15009, United States
Capital Cardiovascular Associates
Camp Hill Pennsylvania, 17011, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Donald Guthrie Foundation for Education and Research
Sayre Pennsylvania, 18840, United States
WellSpan Health
York Pennsylvania, 17405, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Cardiology Consultants
Johnson City Tennessee, 37601, United States
Methodist University Hospital
Memphis Tennessee, 38104, United States
The Stern Cardiovascular Foundation
Memphis Tennessee, 38120, United States
Texas Cardiac Arrhythmia
Austin Texas, 78705, United States
HeartPlace
Bedford Texas, 76021, United States
Advanced Heart Care
Plano Texas, 75093, United States
South Texas Cardiovascular Consultants
San Antonio Texas, 78201, United States
Brooke Army Medical Center
San Antonio Texas, 78234, United States
Cardiovascular Associates of East Texas
Tyler Texas, 75701, United States
McKay-Dee Heart Services
Ogden Utah, 84403, United States
University of Utah Hospital
Salt Lake City Utah, 84132, United States
Cardiovascular Associates Ltd
Chesapeake Virginia, 23320, United States
Charleston Area Medical Center
Charleston West Virginia, 25304, United States
St. Mary's Hospital
Madison Wisconsin, 53715, United States
Cardiac Rhythm Specialists, S.C.
Milwaukee Wisconsin, 53211, United States
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How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

1930

Study ID:

NCT01179477

Recruitment Status:

Completed

Sponsor:


Abbott Medical Devices

How clear is this clinincal trial information?

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