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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quartet 1457Q LV Lead
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center Research
  • Arizona Arrhythmia Research Center
  • Cardiology Associates of Northeast Arkansas
  • Scripps Health
  • Premier Cardiology, Inc.
  • Stanford University Hospital
  • Munroe Regional Medical Center
  • Tallahassee Research Institute
  • Emory University Hospital
  • North Georgia Heart Foundation
  • Iowa Heart Center
  • Central Baptist Hospital
  • One Health Cardiology
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Thoracic Cardiovascular Healthcare Foundation
  • Missouri Heart Center
  • Catholic Medical Center
  • Cardiovascular Associates of Delaware Valley
  • Forsyth Medical Center
  • University Hospitals of Cleveland
  • Oklahoma Heart Institute at Utica
  • Lancaster General Hospital
  • Donald Guthrie Foundation for Education & Research
  • Greenville Health System
  • Erlanger Medical Center
  • The Stern Cardiovascular Foundation
  • The Heart Hospital Baylor Plano
  • Swedish Medical Center - Heart & Vascular
  • St. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Subjects implanted with the Quartet 1457Q LV lead

Outcomes

Primary Outcome Measures

Number of Patients Free From LV Lead-related Complications Through 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.

Secondary Outcome Measures

Full Information

First Posted
September 10, 2015
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02548455
Brief Title
Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study
Official Title
A Clinical Evaluation of the Safety of the St. Jude Medical Quartet 1457Q Left Ventricular Lead, an IDE Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 27, 2015 (Actual)
Primary Completion Date
August 19, 2016 (Actual)
Study Completion Date
March 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
499 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects implanted with the Quartet 1457Q LV lead
Intervention Type
Device
Intervention Name(s)
Quartet 1457Q LV Lead
Primary Outcome Measure Information:
Title
Number of Patients Free From LV Lead-related Complications Through 3 Months
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead. 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. Are 18 years or above, or of legal age to give informed consent specific to state and national law. Exclusion Criteria: Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate 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. Are pregnant or planning pregnancy in the next 6 months Have a life expectancy of less than 24 months due to any condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Delurgio, MD
Organizational Affiliation
Emory University
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Center Research
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Arizona Arrhythmia Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Cardiology Associates of Northeast Arkansas
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Scripps Health
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Premier Cardiology, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Stanford University Hospital
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
North Georgia Heart Foundation
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Central Baptist Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
One Health Cardiology
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42304
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Thoracic Cardiovascular Healthcare Foundation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Missouri Heart Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
Cardiovascular Associates of Delaware Valley
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Oklahoma Heart Institute at Utica
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
Donald Guthrie Foundation for Education & Research
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Erlanger Medical Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
The Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Swedish Medical Center - Heart & Vascular
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
St. Mary's Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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