Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:September 2009
End Date:July 2012

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Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study

The objective of this study is to assess the safety and efficacy of the Quartet™ lead and
Promote Q® device system in a patient population indicated for cardiac resynchronization
therapy.


Inclusion Criteria:

- Approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for
treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)

- Receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker
implant with no prior LV lead placement.

- 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

Exclusion Criteria:

- Have had a recent CVA or TIA within three months of enrollment

- Have a contraindication for an emergency thoracotomy

- Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or
short term contact with heparin

- Have a classification of Status 1 for cardiac transplantation or consideration for
transplantation over the next 3 months

- Have undergone a cardiac transplantation within 40 days of enrollment

- Have had a recent myocardial infarction, unstable angina or cardiac revascularization
(PTCA, Stent or CABG) within 40 days of enrollment

- Are currently participating in a clinical investigation that includes an active
treatment arm

- Are pregnant or planning to become pregnant during the duration of the study

- Have a life expectancy of less than 6 months due to any condition

- Are less than 18 years of age

- Are unable to comply with the follow up schedule
We found this trial at
24
sites
1420 South Central Avenue
Glendale, California 91204
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Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
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Los Angeles, CA
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Atlanta, GA
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Birmingham, AL
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Browns Mills, New Jersey 08015
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Browns Mills, NJ
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41 Burlington Mall Road
Burlington, Massachusetts 01805
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Burlington, MA
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Elyria, Ohio 44035
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Elyria, OH
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Lancaster, Pennsylvania 17603
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Lancaster, PA
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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...
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Lexington, KY
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Little Rock, Arkansas 72205
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Little Rock, AR
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Little Rock, Arkansas 72211
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Little Rock, AR
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Lombard, Illinois 60148
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Lombard, IL
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Memphis, Tennessee 38104
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Memphis, TN
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2901 West Kinnickinnic River Parkway
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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100 Madison Ave
Morristown, New Jersey 7960
(973) 971-5000
Morristown Memorial Hospital Atlantic Health System – comprised of Morristown Medical Center, Overlook Medical Center,...
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Morristown, NJ
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Mountain View, California 94040
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Mountain View, CA
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Nashville, Tennessee 37205
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New York, New York 10029
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New York, NY
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Orlando, Florida 32806
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Orlando, FL
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Sacramento, California 95819
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Sacramento, CA
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Saint Petersburg, FL
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San Diego, California 92037
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San Diego, CA
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