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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:October 27, 2015
End Date:March 21, 2017

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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.

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.

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
We found this trial at
30
sites
Stanford, California 94303
327
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Stanford, CA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
2578
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Boston, MA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
2578
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Boston, MA
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Ocala, Florida 34471
2128
mi
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Ocala, FL
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
1922
mi
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Atlanta, GA
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Chattanooga, Tennessee 37403
1854
mi
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Chattanooga, TN
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11100 Euclid Ave
Cleveland, Ohio 44106
(216) 844-1000
University Hospitals of Cleveland The history of University Hospitals Case Medical Center is linked to...
2036
mi
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Cleveland, OH
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Columbia, Missouri 65201
1462
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Columbia, MO
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Gainesville, Georgia 30501
1944
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Gainesville, GA
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Germantown, Tennessee 38138
1600
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Germantown, TN
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Greenville, South Carolina 29615
2018
mi
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Greenville, SC
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Haddon Heights, New Jersey 08035
2381
mi
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Haddon Heights, NJ
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Huntsville, Alabama 35801
1785
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Huntsville, AL
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1547
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Jonesboro, AR
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La Jolla, California 92037
95
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La Jolla, CA
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
Lancaster General Hospital For more than a century, Lancaster General Hospital has been a leader...
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Lancaster, PA
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1893
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Lansing, MI
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1740 Nicholasville Rd
Lexington, Kentucky 40503
(859) 260-6100
Central Baptist Hospital Located in Lexington, Ky., Baptist Health Lexington offers some of the most...
1879
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Lexington, KY
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700 South Park Street
Madison, Wisconsin 53715
1655
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Madison, WI
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Manchester, New Hampshire 03102
2555
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Manchester, NH
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Newport Beach, California 92663
31
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Newport Beach, CA
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Owensboro, Kentucky 42304
1739
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Owensboro, KY
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Phoenix, Arizona 85006
344
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Plano, Texas 75093
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Plano, TX
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2299
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Sayre, PA
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550 17th Avenue
Seattle, Washington 98122
961
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Seattle, WA
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Tallahassee, Florida 32308
1982
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Tallahassee, FL
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Tulsa, Oklahoma 74104
1252
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Tulsa, OK
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West Des Moines, Iowa 50266
1414
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West Des Moines, IA
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Winston-Salem, North Carolina 27103
2123
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Winston-Salem, NC
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