Quadripolar Pacing Post Approval Study
- Conditions
- Heart Failure
- Interventions
- Device: CRT-D System
- Registration Number
- NCT01555619
- Lead Sponsor
- Abbott Medical Devices
- Brief 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).
- Detailed 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 Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so.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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1971
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CRT-D System CRT-D System St. Jude Medical (SJM) Promote® Q/Promote® Quadra/Unify Quadra™ CRT-D system.
- Primary Outcome Measures
Name Time Method Complication free survival rate related to the CRT-D system 5 years Complication free survival rate through 5 years for complications related to the CRT-D system
Complication free survival rate related to the LV lead 5 years Complication free survival rate at 5 years for complications related to the LV lead
Mean programmed LV lead pacing capture threshold 5 years Mean programmed LV lead pacing capture threshold at 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (71)
Fogarty Institute
🇺🇸Mountain View, California, United States
Cardiovascular Associates, PC
🇺🇸Kingsport, Tennessee, United States
Fletcher Allen Health Care - University Health Center Campus
🇺🇸Burlington, Vermont, United States
Heart Center Research, LLC/Research Center
🇺🇸Huntsville, Alabama, United States
Washington Regional Medical Center
🇺🇸Fayetteville, Arkansas, United States
Comprehensive Cardiovascular
🇺🇸Bakersfield, California, United States
Southeastern Cardiology Consultants PC
🇺🇸Montgomery, Alabama, United States
Scripps Green Hospital
🇺🇸La Jolla, California, United States
USC Unversity Hospital
🇺🇸Los Angeles, California, United States
Premier Cardiology, Inc.
🇺🇸Newport Beach, California, United States
Cardiac Rhythm Specialists, Inc.
🇺🇸Northridge, California, United States
Cardiology Associates Medical Group, Inc.
🇺🇸Ventura, California, United States
St. Joseph Heritage Medical Group
🇺🇸Orange, California, United States
St. Joseph's Medical Center
🇺🇸Stockton, California, United States
Florida Electrophysiology Associates
🇺🇸Atlantis, Florida, United States
Yoel R. Vivas, MD
🇺🇸Boynton Beach, Florida, United States
Jorge Diaz
🇺🇸Lake Mary, Florida, United States
Naples Heart Rhythm Specialists
🇺🇸Naples, Florida, United States
Florida Heart Rhythm Specialists, LLC
🇺🇸Plantation, Florida, United States
Northside Hospital
🇺🇸Saint Petersburg, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Piedmont Heart Institue
🇺🇸Atlanta, Georgia, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Northwest Indiana CardiovascularPhysicians, P.C.
🇺🇸Munster, Indiana, United States
Unity Point Clinic
🇺🇸Cedar Rapids, Iowa, United States
Missouri Baptist Medical Center
🇺🇸Saint Louis, Missouri, United States
Thoracic Cardio Healthcare Foundation
🇺🇸Lansing, Michigan, United States
Stonybrook University Medical Center
🇺🇸Stony Brook, New York, United States
Buffalo Cardiology & Pulmonary Association
🇺🇸Williamsville, New York, United States
Albany Medical College at Albany Medical Center
🇺🇸Albany, New York, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Presbyterian Heart Group
🇺🇸Albuquerque, New Mexico, United States
Caromount Heart
🇺🇸Gastonia, North Carolina, United States
Bryn Mawr Medical Specialists Associates
🇺🇸Bryn Mawr, Pennsylvania, United States
Saint Vincent Consultants in Cardiovascular Diseases
🇺🇸Erie, Pennsylvania, United States
Pee Dee Cardiology Associates, PA
🇺🇸Florence, South Carolina, United States
HeartPlace
🇺🇸Bedford, Texas, United States
Houston Arrhythmia Associates
🇺🇸Houston, Texas, United States
Heart Clinics Northwest
🇺🇸Spokane, Washington, United States
St. Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Medicine School of University Health Care
🇺🇸Salt Lake City, Utah, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Aspirius Heart and Vascular Institute, Research and Education
🇺🇸Wausau, Wisconsin, United States
MedStar Health Research Institute
🇺🇸Baltimore, Maryland, United States
Cardiovascular Consultants of Nevada
🇺🇸Las Vegas, Nevada, United States
Shady Grove Adventist Hospital
🇺🇸Rockville, Maryland, United States
Northeast Cardiology Associates
🇺🇸Bangor, Maine, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Deborah Heart and Lung Center
🇺🇸Browns Mills, New Jersey, United States
Arrythmia Consultants, P.C.
🇺🇸Memphis, Tennessee, United States
Cardiology Associatesof Corpus Christi
🇺🇸Corpus Christi, Texas, United States
Sanford Research
🇺🇸Fargo, North Dakota, United States
Harrisonburg Medical Associations, Inc.
🇺🇸Harrisonburg, Virginia, United States
Morgantown Internal Medicine Group, Inc.
🇺🇸Morgantown, West Virginia, United States
HeartCare Midwest
🇺🇸Peoria, Illinois, United States
EMH Regional Medical Center
🇺🇸Elyria, Ohio, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Cardiology, P.C.
🇺🇸Birmingham, Alabama, United States
Arizona Arrhythmia Research Center
🇺🇸Phoenix, Arizona, United States
Regional Cardiology Associates
🇺🇸Sacramento, California, United States
Sinai Grace Hospital
🇺🇸Detroit, Michigan, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Integris Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Virginia Cardiovascular Specialists
🇺🇸Richmond, Virginia, United States
The International Heart Institute of Montana
🇺🇸Missoula, Montana, United States
Heart Consultants P.C.
🇺🇸Omaha, Nebraska, United States
Cardiovascular Associates of the Delaware Valley
🇺🇸Haddon Heights, New Jersey, United States
Cardiology Consultants
🇺🇸Johnson City, Tennessee, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Munroe Regional Medical Center
🇺🇸Ocala, Florida, United States