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NCT01754064 Clinical Trial

St. Jude Medical Product Longevity and Performance (SCORE) Registry

Heart Disease Clinical Trial

Official title:
St. Jude Medical Product Longevity and Performance (SCORE) Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01754064
Other study ID # 40007941/F
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2007
Est. completion date July 10, 2020

Study information
Verified date May 2021
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10957
Est. completion date July 10, 2020
Est. primary completion date July 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Cardiac Rhythm Management device

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

Sponsors (1)
Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event Free Survival 5 year average
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