Heart Failure Clinical Trial
Quadripolar Pacing Post Approval Study
Summary
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).
Full Description
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 Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so.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.
Eligibility Criteria
Inclusion Criteria:
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).
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.
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:
Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
Have a life expectancy of less than 5 years due to any condition
Be less than 18 years of age
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There are 71 Locations for this study
Birmingham Alabama, 35211, United States
Huntsville Alabama, 35801, United States
Montgomery Alabama, 36116, United States
Phoenix Arizona, 85006, United States
Fayetteville Arkansas, 72703, United States
Little Rock Arkansas, 72211, United States
Bakersfield California, 93309, United States
La Jolla California, 92037, United States
Los Angeles California, 90033, United States
Mountain View California, 94040, United States
Newport Beach California, 92663, United States
Northridge California, 91325, United States
Orange California, 92868, United States
Sacramento California, 95819, United States
Stockton California, 95204, United States
Ventura California, 93003, United States
Atlantis Florida, 33462, United States
Boynton Beach Florida, 33437, United States
Lake Mary Florida, 32746, United States
Naples Florida, 34102, United States
Ocala Florida, 34471, United States
Plantation Florida, 33324, United States
Saint Petersburg Florida, 33709, United States
Weston Florida, 33331, United States
Atlanta Georgia, 30309, United States
Peoria Illinois, 61614, United States
Fort Wayne Indiana, 46805, United States
Munster Indiana, 46321, United States
Cedar Rapids Iowa, 52403, United States
Lexington Kentucky, 40503, United States
Bangor Maine, 04401, United States
Baltimore Maryland, 21237, United States
Rockville Maryland, 20850, United States
Burlington Massachusetts, 01805, United States
Detroit Michigan, 48235, United States
Lansing Michigan, 48910, United States
Saint Louis Missouri, 63131, United States
Missoula Montana, 59802, United States
Omaha Nebraska, 68122, United States
Las Vegas Nevada, 89109, United States
Browns Mills New Jersey, 08015, United States
Haddon Heights New Jersey, 08035, United States
Albuquerque New Mexico, 87106, United States
Albany New York, 12208, United States
Stony Brook New York, 11794, United States
Williamsville New York, 14221, United States
Chapel Hill North Carolina, 27599, United States
Gastonia North Carolina, 28054, United States
Fargo North Dakota, 58122, United States
Cleveland Ohio, 44195, United States
Elyria Ohio, 44035, United States
Oklahoma City Oklahoma, 73112, United States
Bryn Mawr Pennsylvania, 19010, United States
Erie Pennsylvania, 16502, United States
Lancaster Pennsylvania, 17603, United States
Philadelphia Pennsylvania, 19104, United States
Florence South Carolina, 29506, United States
Johnson City Tennessee, 37601, United States
Kingsport Tennessee, 37660, United States
Memphis Tennessee, 38104, United States
Nashville Tennessee, 37205, United States
Bedford Texas, 76021, United States
Corpus Christi Texas, 78404, United States
Houston Texas, 77024, United States
Salt Lake City Utah, 84132, United States
Burlington Vermont, 05401, United States
Harrisonburg Virginia, 22801, United States
Richmond Virginia, 23229, United States
Spokane Washington, 99204, United States
Morgantown West Virginia, 26505, United States
Wausau Wisconsin, 54401, United States
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