Clinical trial NCT01179477: QuickFlex Micro Left Ventricular Lead Post Approval Study
Official title: QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Left heart pacing lead
Cardiac resynchronization therapy (CRT)
Heart failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 1930
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an approved indication for implantation of a CRT-D system

Brief 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.

Detailed 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

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

Primary outcomes:
measure: Percent of Participants Alive and Without a Left Ventricular Lead-related Complication
timeFrame: 5 years
measure: Left Ventricular Bipolar Pacing Capture Threshold
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates P.C.
state: Alabama
city: Birmingham
country: United States
facility: University Hospital - Univ. of Alabama at Birmingham (UAB)
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC.
state: Alabama
city: Anchorage
country: United States
facility: Alaska Heart Institute
state: Alaska
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Cardiology
state: Arkansas
city: Little Rock
country: United States
facility: St. Vincent Heart Clinic Arkansas
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Springdale
country: United States
facility: Northwest Cardiology
state: Arkansas
city: Glendale
country: United States
facility: Glendale Memorial Hospital and Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: San Diego
country: United States
facility: University of California at San Diego (UCSD) Medical Center
state: California
city: Santa Barbara
country: United States
facility: Claudio Bonometti MD, Inc
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA
state: California
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Jacksonville
country: United States
facility: Shands Jacksonville
state: Florida
city: Kissimmee
country: United States
facility: Naushad Shaik, MD
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Orlando
country: United States
facility: Usman R. Siddiqui, MD
state: Florida
city: Orlando
country: United States
facility: Orlando Heart Center
state: Florida
city: Rockledge
country: United States
facility: Brevard Cardiovascular Research Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Cardiovascular Services
state: Florida
city: Athens
country: United States
facility: Athens Regional Medical Center
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Hospital
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Newburgh
country: United States
facility: The Heart Group
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: Mid-America Cardiology Associates, PC
state: Kansas
city: Ashland
country: United States
facility: King's Daughters Medical Center
state: Kentucky
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Bluegrass Heart Specialists
state: Kentucky
city: Salisbury
country: United States
facility: Peninsula Cardiology Associates, P.A.
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: Trinity Health-Michigan d/b/a Michigan Heart
state: Michigan
city: Lansing
country: United States
facility: Thoracic Cardio Healthcare Found. (aka Sparrow Research)
state: Michigan
city: Midland
country: United States
facility: MidMichigan Physicians Group
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Tupelo
country: United States
facility: Cardiology Associates of North Mississippi
state: Mississippi
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Omaha
country: United States
facility: Heart Consultants P.C.
state: Nebraska
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: West Orange
country: United States
facility: New Jersey Cardiology Associates
state: New Jersey
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Greensboro
country: United States
facility: LeBauer HeartCare
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Medical Center Clinical Sciences
state: North Carolina
city: Kettering
country: United States
facility: Primed Cardiology/Kettering Medical Center Network
state: Ohio
city: Steubenville
country: United States
facility: Regional Cardiovascular Medical Center
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic
state: Ohio
city: Youngstown
country: United States
facility: St. Elizabeth Health Center
state: Ohio
city: Portland
country: United States
facility: Providence Heart and Vascular Institute
state: Oregon
city: Beaver
country: United States
facility: Tri-State Medical Group Cardiology
state: Pennsylvania
city: Camp Hill
country: United States
facility: Capital Cardiovascular Associates
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Sayre
country: United States
facility: Donald Guthrie Foundation for Education and Research
state: Pennsylvania
city: York
country: United States
facility: WellSpan Health
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Johnson City
country: United States
facility: Cardiology Consultants
state: Tennessee
city: Memphis
country: United States
facility: Methodist University Hospital
state: Tennessee
city: Memphis
country: United States
facility: The Stern Cardiovascular Foundation
state: Tennessee
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
city: Bedford
country: United States
facility: HeartPlace
state: Texas
city: Plano
country: United States
facility: Advanced Heart Care
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas
state: Texas
city: Ogden
country: United States
facility: McKay-Dee Heart Services
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Chesapeake
country: United States
facility: Cardiovascular Associates Ltd
state: Virginia
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Madison
country: United States
facility: St. Mary's Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Cardiac Rhythm Specialists, S.C.
state: Wisconsin
Study officials:
affiliation: Abbott Medical Devices
name: Clay Cohorn
role: STUDY_DIRECTOR
References: