QuickFlex Micro Left Ventricular Lead Post Approval Study

QuickFlex® μ Model 1258T Left Heart Pacing Lead Post Approval Study

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Implantation of a QuickFlex® μ Model 1258T 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

• Study Type: Observational
• Enrollment (Actual): 1930

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an approved indication for implantation of a CRT-D system

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants Alive and Without a Left Ventricular Lead-related Complication	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).	5 years
Left Ventricular Bipolar Pacing Capture Threshold	Mean left ventricular bipolar pacing capture threshold measured at 0.5 ms pulse width at 5 years of follow-up	5 years

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Director: Clay Cohorn, Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2010
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: August 9, 2010
• First Submitted That Met QC Criteria: August 9, 2010
• First Posted (Estimate): August 11, 2010

Study Record Updates

• Last Update Posted (Actual): August 12, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Heart failure; Left heart pacing lead; Cardiac resynchronization therapy (CRT)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: CRD561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No