Clinical trial NCT01555619: Quadripolar Pacing Post Approval Study
Official title: Quadripolar Pacing Post Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Left heart pacing lead
Cardiac resynchronization therapy (CRT)
Heart Failure
Quadripolar pacing
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 1971
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients indicated for CRT.

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 Patients who have an unsuccessful implant will be followed for 30 days for any adverse events and then withdrawn from the study, or may have an implant reattempted if the physician chooses to do so.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

Eligibility criteria: 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

Primary outcomes:
measure: Complication free survival rate related to the CRT-D system
timeFrame: 5 years
measure: Complication free survival rate related to the LV lead
timeFrame: 5 years
measure: Mean programmed LV lead pacing capture threshold
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiology, P.C.
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC/Research Center
state: Alabama
city: Montgomery
country: United States
facility: Southeastern Cardiology Consultants PC
state: Alabama
city: Phoenix
country: United States
facility: Arizona Arrhythmia Research Center
state: Arizona
city: Fayetteville
country: United States
facility: Washington Regional Medical Center
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Cardiovascular
state: California
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
city: Los Angeles
country: United States
facility: USC Unversity Hospital
state: California
city: Mountain View
country: United States
facility: Fogarty Institute
state: California
city: Newport Beach
country: United States
facility: Premier Cardiology, Inc.
state: California
city: Northridge
country: United States
facility: Cardiac Rhythm Specialists, Inc.
state: California
city: Orange
country: United States
facility: St. Joseph Heritage Medical Group
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Stockton
country: United States
facility: St. Joseph's Medical Center
state: California
city: Ventura
country: United States
facility: Cardiology Associates Medical Group, Inc.
state: California
city: Atlantis
country: United States
facility: Florida Electrophysiology Associates
state: Florida
city: Boynton Beach
country: United States
facility: Yoel R. Vivas, MD
state: Florida
city: Lake Mary
country: United States
facility: Jorge Diaz
state: Florida
city: Naples
country: United States
facility: Naples Heart Rhythm Specialists
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Medical Center
state: Florida
city: Plantation
country: United States
facility: Florida Heart Rhythm Specialists, LLC
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institue
state: Georgia
city: Peoria
country: United States
facility: HeartCare Midwest
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Munster
country: United States
facility: Northwest Indiana CardiovascularPhysicians, P.C.
state: Indiana
city: Cedar Rapids
country: United States
facility: Unity Point Clinic
state: Iowa
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Bangor
country: United States
facility: Northeast Cardiology Associates
state: Maine
city: Baltimore
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Rockville
country: United States
facility: Shady Grove Adventist Hospital
state: Maryland
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Detroit
country: United States
facility: Sinai Grace Hospital
state: Michigan
city: Lansing
country: United States
facility: Thoracic Cardio Healthcare Foundation
state: Michigan
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Missoula
country: United States
facility: The International Heart Institute of Montana
state: Montana
city: Omaha
country: United States
facility: Heart Consultants P.C.
state: Nebraska
city: Las Vegas
country: United States
facility: Cardiovascular Consultants of Nevada
state: Nevada
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Haddon Heights
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Albuquerque
country: United States
facility: Presbyterian Heart Group
state: New Mexico
city: Albany
country: United States
facility: Albany Medical College at Albany Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stonybrook University Medical Center
state: New York
city: Williamsville
country: United States
facility: Buffalo Cardiology & Pulmonary Association
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Gastonia
country: United States
facility: Caromount Heart
state: North Carolina
city: Fargo
country: United States
facility: Sanford Research
state: North Dakota
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Elyria
country: United States
facility: EMH Regional Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Medical Center
state: Oklahoma
city: Bryn Mawr
country: United States
facility: Bryn Mawr Medical Specialists Associates
state: Pennsylvania
city: Erie
country: United States
facility: Saint Vincent Consultants in Cardiovascular Diseases
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Florence
country: United States
facility: Pee Dee Cardiology Associates, PA
state: South Carolina
city: Johnson City
country: United States
facility: Cardiology Consultants
state: Tennessee
city: Kingsport
country: United States
facility: Cardiovascular Associates, PC
state: Tennessee
city: Memphis
country: United States
facility: Arrythmia Consultants, P.C.
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital
state: Tennessee
city: Bedford
country: United States
facility: HeartPlace
state: Texas
city: Corpus Christi
country: United States
facility: Cardiology Associatesof Corpus Christi
state: Texas
city: Houston
country: United States
facility: Houston Arrhythmia Associates
state: Texas
city: Salt Lake City
country: United States
facility: Medicine School of University Health Care
state: Utah
city: Burlington
country: United States
facility: Fletcher Allen Health Care - University Health Center Campus
state: Vermont
city: Harrisonburg
country: United States
facility: Harrisonburg Medical Associations, Inc.
state: Virginia
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
city: Spokane
country: United States
facility: Heart Clinics Northwest
state: Washington
city: Morgantown
country: United States
facility: Morgantown Internal Medicine Group, Inc.
state: West Virginia
city: Wausau
country: United States
facility: Aspirius Heart and Vascular Institute, Research and Education
state: Wisconsin
Study officials:
affiliation: Deborah Heart and Lung Center
name: Raffaele Corbisiero, MD
role: STUDY_CHAIR
References: