QuickFlex Micro Left Ventricular Lead Post Approval Study

Completed

Conditions: Heart Failure

Registration Number: NCT01179477

Lead Sponsor: Abbott Medical Devices

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1930

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication	5 years	Percent of Participants Alive and Without a Left Ventricular Lead-related Complication at 5 years of follow-up. Per FDA, data from IDE subjects who did not consent to rollover into the post approval study at sites participating in the post approval study, were included in this analysis (see clinical investigational protocol).
Left Ventricular Bipolar Pacing Capture Threshold	5 years	Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (77): Claudio Bonometti MD, Inc
🇺🇸
Santa Barbara, California, United States
Heart Center Research, LLC.
🇺🇸
Huntsville, Alabama, United States
Alaska Heart Institute
🇺🇸
Anchorage, Alaska, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸
Los Angeles, California, United States
Glendale Memorial Hospital and Medical Center
🇺🇸
Glendale, California, United States
Arizona Arrhythmia Consultants
🇺🇸
Scottsdale, Arizona, United States
Northwest Cardiology
🇺🇸
Springdale, Arkansas, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA
🇺🇸
Torrance, California, United States
Naushad Shaik, MD
🇺🇸
Kissimmee, Florida, United States
Shands Jacksonville
🇺🇸
Jacksonville, Florida, United States
Munroe Regional Medical Center
🇺🇸
Ocala, Florida, United States
Athens Regional Medical Center
🇺🇸
Athens, Georgia, United States
Brevard Cardiovascular Research Associates, Inc.
🇺🇸
Rockledge, Florida, United States
Redmond Regional Medical Center
🇺🇸
Rome, Georgia, United States
St. Joseph's Hospital
🇺🇸
Atlanta, 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
King's Daughters Medical Center
🇺🇸
Ashland, Kentucky, United States
Peninsula Cardiology Associates, P.A.
🇺🇸
Salisbury, Maryland, United States
MidMichigan Physicians Group
🇺🇸
Midland, Michigan, United States
Thoracic Cardio Healthcare Found. (aka Sparrow Research)
🇺🇸
Lansing, Michigan, United States
Cardiology Associates of North Mississippi
🇺🇸
Tupelo, Mississippi, United States
Missouri Baptist Medical Center
🇺🇸
Saint Louis, Missouri, United States
AtlantiCare Regional Medical Center
🇺🇸
Pomona, New Jersey, United States
New Jersey Cardiology Associates
🇺🇸
West Orange, New Jersey, United States
Lourdes Cardiology Services
🇺🇸
Voorhees, New Jersey, United States
LeBauer HeartCare
🇺🇸
Greensboro, North Carolina, United States
Lenox Hill Hospital
🇺🇸
New York, New York, United States
Primed Cardiology/Kettering Medical Center Network
🇺🇸
Kettering, Ohio, United States
Regional Cardiovascular Medical Center
🇺🇸
Steubenville, Ohio, United States
St. Elizabeth Health Center
🇺🇸
Youngstown, Ohio, 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
The Toledo Hospital
🇺🇸
Toledo, Ohio, United States
Christiana Hospital
🇺🇸
Newark, Delaware, United States
Jackson Heart Clinic
🇺🇸
Jackson, Mississippi, United States
Tri-State Medical Group Cardiology
🇺🇸
Beaver, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Capital Cardiovascular Associates
🇺🇸
Camp Hill, Pennsylvania, United States
WellSpan Health
🇺🇸
York, Pennsylvania, United States
Donald Guthrie Foundation for Education and Research
🇺🇸
Sayre, Pennsylvania, United States
The Stern Cardiovascular Foundation
🇺🇸
Memphis, Tennessee, United States
Cardiology Consultants
🇺🇸
Johnson City, Tennessee, United States
Methodist University Hospital
🇺🇸
Memphis, Tennessee, United States
Advanced Heart Care
🇺🇸
Plano, Texas, United States
HeartPlace
🇺🇸
Bedford, Texas, United States
McKay-Dee Heart Services
🇺🇸
Ogden, Utah, United States
Cardiovascular Associates of East Texas
🇺🇸
Tyler, Texas, United States
Cardiovascular Associates Ltd
🇺🇸
Chesapeake, Virginia, United States
Charleston Area Medical Center
🇺🇸
Charleston, West Virginia, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
University of California at San Diego (UCSD) Medical Center
🇺🇸
San Diego, California, United States
Mid-America Cardiology Associates, PC
🇺🇸
Kansas City, Kansas, United States
Cardiovascular Associates P.C.
🇺🇸
Birmingham, Alabama, United States
University Hospital - Univ. of Alabama at Birmingham (UAB)
🇺🇸
Birmingham, Alabama, United States
Arizona Arrhythmia Research Center
🇺🇸
Phoenix, Arizona, United States
Regional Cardiology Associates
🇺🇸
Sacramento, California, United States
Usman R. Siddiqui, MD
🇺🇸
Orlando, Florida, United States
Orlando Heart Center
🇺🇸
Orlando, Florida, United States
University of South Florida, Cardiovascular Services
🇺🇸
Tampa, Florida, United States
Central Baptist Hospital
🇺🇸
Lexington, Kentucky, United States
Norton Bluegrass Heart Specialists
🇺🇸
Louisville, Kentucky, United States
Trinity Health-Michigan d/b/a Michigan Heart
🇺🇸
Ann Arbor, Michigan, United States
Heart Consultants P.C.
🇺🇸
Omaha, Nebraska, United States
Wake Forest University Medical Center Clinical Sciences
🇺🇸
Winston-Salem, North Carolina, United States
Providence Heart and Vascular Institute
🇺🇸
Portland, Oregon, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
South Texas Cardiovascular Consultants
🇺🇸
San Antonio, Texas, United States
Brooke Army Medical Center
🇺🇸
San Antonio, Texas, United States
University of Utah Hospital
🇺🇸
Salt Lake City, Utah, United States
St. Mary's Hospital
🇺🇸
Madison, Wisconsin, United States
Cardiac Rhythm Specialists, S.C.
🇺🇸
Milwaukee, Wisconsin, United States
Texas Cardiac Arrhythmia
🇺🇸
Austin, Texas, United States
Toledo Clinic
🇺🇸
Toledo, Ohio, United States