Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study

January 31, 2019 updated by: Abbott Medical Devices

A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study

The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead.

A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide.

All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.

Study Type

Interventional

Enrollment (Actual)

499

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Arizona Arrhythmia Research Center
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Cardiology Associates of Northeast Arkansas
    • California
      • La Jolla, California, United States, 92037
        • Scripps Health
      • Newport Beach, California, United States, 92663
        • Premier Cardiology, Inc.
      • Stanford, California, United States, 94305
        • Stanford University Hospital
    • Florida
      • Ocala, Florida, United States, 34471
        • Munroe Regional Medical Center
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Gainesville, Georgia, United States, 30501
        • North Georgia Heart Foundation
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Central Baptist Hospital
      • Owensboro, Kentucky, United States, 42304
        • One Health Cardiology
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Thoracic Cardiovascular Healthcare Foundation
    • Missouri
      • Columbia, Missouri, United States, 65201
        • Missouri Heart Center
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
    • New Jersey
      • Haddon Heights, New Jersey, United States, 08035
        • Cardiovascular Associates of Delaware Valley
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Forsyth Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Heart Institute at Utica
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17602
        • Lancaster General Hospital
      • Sayre, Pennsylvania, United States, 18840
        • Donald Guthrie Foundation for Education & Research
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center
      • Germantown, Tennessee, United States, 38138
        • The Stern Cardiovascular Foundation
    • Texas
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center - Heart & Vascular
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:

    " to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR " to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure.

  2. Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.
  3. Have the ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
  4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

  1. Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt
  2. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
  3. Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager.
  4. Are pregnant or planning pregnancy in the next 6 months
  5. Have a life expectancy of less than 24 months due to any condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Subjects implanted with the Quartet 1457Q LV lead
Device: Quartet 1457Q LV Lead

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients Free From LV Lead-related Complications Through 3 Months
Time Frame: 3 months
A complication is defined as a Serious Adverse Device Effect related to the Quartet 1457Q lead. A Serious Adverse Device Effect is an event related to the use of a medical device that led to death, a life-threatening illness or injury, a permanent impairment to a body structure or a body function, an in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body, a malignant tumor OR fetal distress, fetal death or a congenital abnormality or birth defect.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Chair: David Delurgio, MD, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2015

Primary Completion (Actual)

August 19, 2016

Study Completion (Actual)

March 21, 2017

Study Registration Dates

First Submitted

September 10, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 14, 2015

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD 616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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