Clinical trial NCT01754064: St. Jude Medical Product Longevity and Performance (SCORE) Registry
Official title: St. Jude Medical Product Longevity and Performance (SCORE) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Tachycardia
Heart Disease
Keywords: Bradycardia
Tachycardia
Arrhythmia
ICD
pacemaker
pacing lead
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 10957
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient indicated for a cardiac rhythm management (CRM) product like ICD, pacemaker, CRT-D, CRT-P, leads, etc. would be eligible for participation in the study.

Brief summary: SCORE is an active, prospective, non-randomized, multi-center outcome-oriented registry of patients implanted with St Jude Medical (SJM) market-released cardiac rhythm management (CRM) products. This registry will be conducted in the United States (US).

The primary purpose of the registry is to evaluate and publish acute and long-term performance of market-released SJM CRM products by analyzing product survival probabilities. Product status and any related adverse events will be collected to measure survival probabilities.


Eligibility criteria: Enrollment Criteria:

* Patient has a standard indication for a CRM implantable device.
* Patient is implanted with at least one new market-released SJM CRM product from a list provided by SJM (e.g pacemaker, ICD, CRT-D, CRT-P, pacing/sensing lead, defibrillation lead) within the last 90 days.
* Complete system implant information (e.g. model, serial number, location) is available at enrollment.
* Any product-related adverse event information at implant is available at enrollment.
* Patient or appropriate legal guardian is willing to provide authorization for registry participation.

Primary outcomes:
measure: Event Free Survival
timeFrame: 5 year average
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC.
state: Alabama
city: Mobile
country: United States
facility: Cardiology Associates of Mobile, Inc.
state: Alabama
city: Anchorage
country: United States
facility: Alaska Heart Institute
state: Alaska
city: Phoenix
country: United States
facility: Arizona Cardiovascular Research Center
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Arrhythmia Consultants
state: Arizona
city: Tucson
country: United States
facility: Pima Heart Physicians, PC
state: Arizona
city: Springdale
country: United States
facility: Northwest Cardiology
state: Arkansas
city: Burbank
country: United States
facility: Raymond Schaerf, MD
state: California
city: Fresno
country: United States
facility: California Heart Medical Associates
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital and Medical Center
state: California
city: Los Angeles
country: United States
facility: Jeffrey Goodman MD
state: California
city: Reseda
country: United States
facility: Cardiac Rhythm Specialists, Inc.
state: California
city: Riverside
country: United States
facility: Truong Duong MD
state: California
city: Sacramento
country: United States
facility: Mercy Medical Group - Cardiology
state: California
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Littleton
country: United States
facility: South Denver Cardiology Associates PC
state: Colorado
city: New Canaan
country: United States
facility: Michael Pittaro MD
state: Connecticut
city: Norwalk
country: United States
facility: Cardiology Associates of Fairfield County, PC
state: Connecticut
city: Boca Raton
country: United States
facility: Cardiac Arrhythmia Services
state: Florida
city: Jacksonville
country: United States
facility: Shands Jacksonville
state: Florida
city: Lake Mary
country: United States
facility: Jorge Diaz, M.D., P.A.
state: Florida
city: Naples
country: United States
facility: Naples Heart Rhythm Specialists, PA
state: Florida
city: Ocala
country: United States
facility: Central Florida Heart Center
state: Florida
city: Pensacola
country: United States
facility: Cardiology Consultants - Baptist Campus
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Institute - Buckhead Location
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Rome
country: United States
facility: Harbin Clinic Southeastern Cardiovascular Institute
state: Georgia
city: Chicago
country: United States
facility: North Shore Cardiology
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: Mid-America Cardiology Associates, PC
state: Kansas
city: Ashland
country: United States
facility: King's Daughters Medical Center
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Rockville
country: United States
facility: Cardiac Associates PC
state: Maryland
city: Springfield
country: United States
facility: Pioneer Valley Cardiology
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: St. John Hospital and Medical Center
state: Michigan
city: Lansing
country: United States
facility: Thoracic Cardio Healthcare Found. (aka Sparrow Clinical Research Institute)
state: Michigan
city: Saginaw
country: United States
facility: Ascension St. Mary's Research Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Reno
country: United States
facility: Renown Institute for Heart and Vascular Health
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Morristown Memorial Hospital (Atlantic Health System)
state: New Jersey
city: West Orange
country: United States
facility: New Jersey Cardiology Associates
state: New Jersey
city: Buffalo
country: United States
facility: Trinity Medical WNY, PC
state: New York
city: New York
country: United States
facility: Manhattan Cardiac Arrhythmia Consultants
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Rochester
country: United States
facility: Westfall Cardiology LLP
state: New York
city: Akron
country: United States
facility: Northeast Ohio Cardiovascular Specialists
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Toledo
country: United States
facility: Northwest Ohio Cardiology Consultants
state: Ohio
city: Erie
country: United States
facility: Saint Vincent Consultants in Cardiovascular Diseases
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Columbia
country: United States
facility: Lexington Cardiology
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Jackson
country: United States
facility: Apex Cardiology
state: Tennessee
city: Memphis
country: United States
facility: Memphis Cardiac Care Center
state: Tennessee
city: Nashville
country: United States
facility: The Heart Group, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Page-Campbell Heart Institute
state: Tennessee
city: Dallas
country: United States
facility: Dallas Heart Group
state: Texas
city: Humble
country: United States
facility: Cardiovascular Association, P.L.L.C.
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas
state: Texas
city: Salt Lake City
country: United States
facility: Medicine School of University Health Care
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Midlothian
country: United States
facility: Cardiovascular Associates of Virginia
state: Virginia
city: Kirkland
country: United States
facility: Eastside Cardiology Associates
state: Washington
city: Spokane
country: United States
facility: Kootenai Heart Clinics
state: Washington
city: Charleston
country: United States
facility: Dr. Edmundo Figueroa, MD
state: West Virginia
city: Morgantown
country: United States
facility: Cardiac & Vascular of Monongalia General Hospital
state: West Virginia
city: Madison
country: United States
facility: Dean Foundation
state: Wisconsin
Study officials:
affiliation: Abbott Medical Devices
name: Grant Kim
role: STUDY_DIRECTOR
References: