Quadripolar Pacing Post Approval Study



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/10/2019
Start Date:February 15, 2012
End Date:March 15, 2019

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The purpose of this post-approval study is to evaluate the acute and chronic performance of a
Quadripolar CRT-D device system in a patient population indicated for cardiac
resynchronization therapy (CRT).

Quad PAS is a multi-center, post-approval study. Patients who meet inclusion/exclusion
criteria will have an attempted implant of a Quadripolar CRT-D device system (device and left
ventricular (LV) lead). Patients who have an unsuccessful implant will be followed for 30
days for any adverse events and then withdrawn from the study, or may have an implant
reattempted if the physician chooses to do so. Patients enrolled in the study will be
followed at 6 months, and every 6 months thereafter, for 60 months of follow up (5 years).
After patients complete 60 months of follow-up, their participation in the study will be
terminated.

Inclusion Criteria:

1. Approved indication per current American College of Cardiology/American Heart
Association/Heart Rhythm Society guidelines for implantation of a CRT-D system for
treatment of heart failure or life threatening ventricular tachyarrhythmia(s).

2. Participated in the Promote® Q CRT-D and Quartet™ Left Ventricular Heart Lead Study
(Investigational Device Exemption (IDE) study), or are receiving a new Quadripolar
CRT-D device system implant or are undergoing an upgrade from an existing implantable
cardioverter-defibrillator or pacemaker implant with no prior LV lead placement.

3. 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:

1. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate

2. Have a life expectancy of less than 5 years due to any condition

3. Be less than 18 years of age
We found this trial at
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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6071 West Outer Drive
Detroit, Michigan 48235
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Ocala, Florida 34471
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
Cleveland Clinic Florida Cleveland Clinic Florida, located in Weston, West Palm Beach, Palm Beach Gardens...
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Albuquerque, New Mexico 87106
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Atlanta, Georgia 30309
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Atlantis, Florida 33462
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Bakersfield, California 93309
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Baltimore, Maryland 21237
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Bangor, Maine 04401
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Bedford, Texas 76021
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Birmingham, Alabama 35211
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Boynton Beach, Florida 33437
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Browns Mills, New Jersey 08015
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Bryn Mawr, Pennsylvania 19010
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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Cedar Rapids, Iowa 53402
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Corpus Christi, Texas 78404
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Elyria, Ohio 44035
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Fargo, North Dakota 58122
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Fayetteville, Arkansas 72703
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Fort Wayne, Indiana 46805
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Gastonia, North Carolina 28054
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Haddon Heights, New Jersey 08035
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Houston, Texas 77024
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Huntsville, Alabama 35801
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Johnson City, Tennessee 37601
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La Jolla, California 92037
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Lake Mary, Florida 32746
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555 N Duke St
Lancaster, Pennsylvania 17602
(717) 544-5511
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Lansing, Michigan 48910
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Las Vegas, Nevada 89109
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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...
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Little Rock, Arkansas 72211
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Los Angeles, California 90033
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Memphis, Tennessee 38104
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Morgantown, West Virginia 26505
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Sacramento, California 95819
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3015 North Ballas Road
Saint Louis, Missouri 63131
(314) 996-5000
Missouri Baptist Medical Center You just feel it. The smile that greets you. The hand...
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Saint Petersburg, Florida 33709
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Spokane, Washington 99204
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Stockton, California 95204
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100 Nicolls Road
Stony Brook, New York 11794
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Ventura, California 93003
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