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).

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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 Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so.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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

1971

Study ID:

NCT01555619

Recruitment Status:

Completed

Sponsor:

Abbott Medical Devices

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There are 71 Locations for this study

See Locations Near You

Cardiology, P.C.
Birmingham Alabama, 35211, United States
Heart Center Research, LLC/Research Center
Huntsville Alabama, 35801, United States
Southeastern Cardiology Consultants PC
Montgomery Alabama, 36116, United States
Arizona Arrhythmia Research Center
Phoenix Arizona, 85006, United States
Washington Regional Medical Center
Fayetteville Arkansas, 72703, United States
Arkansas Heart Hospital
Little Rock Arkansas, 72211, United States
Comprehensive Cardiovascular
Bakersfield California, 93309, United States
Scripps Green Hospital
La Jolla California, 92037, United States
USC Unversity Hospital
Los Angeles California, 90033, United States
Fogarty Institute
Mountain View California, 94040, United States
Premier Cardiology, Inc.
Newport Beach California, 92663, United States
Cardiac Rhythm Specialists, Inc.
Northridge California, 91325, United States
St. Joseph Heritage Medical Group
Orange California, 92868, United States
Regional Cardiology Associates
Sacramento California, 95819, United States
St. Joseph's Medical Center
Stockton California, 95204, United States
Cardiology Associates Medical Group, Inc.
Ventura California, 93003, United States
Florida Electrophysiology Associates
Atlantis Florida, 33462, United States
Yoel R. Vivas, MD
Boynton Beach Florida, 33437, United States
Jorge Diaz
Lake Mary Florida, 32746, United States
Naples Heart Rhythm Specialists
Naples Florida, 34102, United States
Munroe Regional Medical Center
Ocala Florida, 34471, United States
Florida Heart Rhythm Specialists, LLC
Plantation Florida, 33324, United States
Northside Hospital
Saint Petersburg Florida, 33709, United States
Cleveland Clinic Florida
Weston Florida, 33331, United States
Piedmont Heart Institue
Atlanta Georgia, 30309, United States
HeartCare Midwest
Peoria Illinois, 61614, United States
Parkview Research Center
Fort Wayne Indiana, 46805, United States
Northwest Indiana CardiovascularPhysicians, P.C.
Munster Indiana, 46321, United States
Unity Point Clinic
Cedar Rapids Iowa, 52403, United States
Central Baptist Hospital
Lexington Kentucky, 40503, United States
Northeast Cardiology Associates
Bangor Maine, 04401, United States
MedStar Health Research Institute
Baltimore Maryland, 21237, United States
Shady Grove Adventist Hospital
Rockville Maryland, 20850, United States
Lahey Clinic
Burlington Massachusetts, 01805, United States
Sinai Grace Hospital
Detroit Michigan, 48235, United States
Thoracic Cardio Healthcare Foundation
Lansing Michigan, 48910, United States
Missouri Baptist Medical Center
Saint Louis Missouri, 63131, United States
The International Heart Institute of Montana
Missoula Montana, 59802, United States
Heart Consultants P.C.
Omaha Nebraska, 68122, United States
Cardiovascular Consultants of Nevada
Las Vegas Nevada, 89109, United States
Deborah Heart and Lung Center
Browns Mills New Jersey, 08015, United States
Cardiovascular Associates of the Delaware Valley
Haddon Heights New Jersey, 08035, United States
Presbyterian Heart Group
Albuquerque New Mexico, 87106, United States
Albany Medical College at Albany Medical Center
Albany New York, 12208, United States
Stonybrook University Medical Center
Stony Brook New York, 11794, United States
Buffalo Cardiology & Pulmonary Association
Williamsville New York, 14221, United States
University of North Carolina at Chapel Hill
Chapel Hill North Carolina, 27599, United States
Caromount Heart
Gastonia North Carolina, 28054, United States
Sanford Research
Fargo North Dakota, 58122, United States
The Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
EMH Regional Medical Center
Elyria Ohio, 44035, United States
Integris Baptist Medical Center
Oklahoma City Oklahoma, 73112, United States
Bryn Mawr Medical Specialists Associates
Bryn Mawr Pennsylvania, 19010, United States
Saint Vincent Consultants in Cardiovascular Diseases
Erie Pennsylvania, 16502, United States
Lancaster General Hospital
Lancaster Pennsylvania, 17603, United States
Hospital of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Pee Dee Cardiology Associates, PA
Florence South Carolina, 29506, United States
Cardiology Consultants
Johnson City Tennessee, 37601, United States
Cardiovascular Associates, PC
Kingsport Tennessee, 37660, United States
Arrythmia Consultants, P.C.
Memphis Tennessee, 38104, United States
St. Thomas Hospital
Nashville Tennessee, 37205, United States
HeartPlace
Bedford Texas, 76021, United States
Cardiology Associatesof Corpus Christi
Corpus Christi Texas, 78404, United States
Houston Arrhythmia Associates
Houston Texas, 77024, United States
Medicine School of University Health Care
Salt Lake City Utah, 84132, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington Vermont, 05401, United States
Harrisonburg Medical Associations, Inc.
Harrisonburg Virginia, 22801, United States
Virginia Cardiovascular Specialists
Richmond Virginia, 23229, United States
Heart Clinics Northwest
Spokane Washington, 99204, United States
Morgantown Internal Medicine Group, Inc.
Morgantown West Virginia, 26505, United States
Aspirius Heart and Vascular Institute, Research and Education
Wausau Wisconsin, 54401, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

1971

Study ID:

NCT01555619

Recruitment Status:

Completed

Sponsor:


Abbott Medical Devices

How clear is this clinincal trial information?

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