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

May 7, 2021 updated by: Abbott Medical Devices

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10957

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research, LLC.
      • Mobile, Alabama, United States, 36608
        • Cardiology Associates of Mobile, Inc.
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Heart Institute
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Cardiovascular Research Center
      • Scottsdale, Arizona, United States, 85251
        • Arizona Arrhythmia Consultants
      • Tucson, Arizona, United States, 85712
        • Pima Heart Physicians, PC
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Northwest Cardiology
    • California
      • Burbank, California, United States, 91505
        • Raymond Schaerf, MD
      • Fresno, California, United States, 93720
        • California Heart Medical Associates
      • Glendale, California, United States, 91204-2508
        • Glendale Memorial Hospital and Medical Center
      • Los Angeles, California, United States, 90048
        • Jeffrey Goodman MD
      • Reseda, California, United States, 91335
        • Cardiac Rhythm Specialists, Inc.
      • Riverside, California, United States, 92501
        • Truong Duong MD
      • Sacramento, California, United States, 95819
        • Mercy Medical Group - Cardiology
      • Santa Monica, California, United States, 90404
        • Pacific Heart Institute
    • Colorado
      • Littleton, Colorado, United States, 80120
        • South Denver Cardiology Associates PC
    • Connecticut
      • New Canaan, Connecticut, United States, 06840
        • Michael Pittaro MD
      • Norwalk, Connecticut, United States, 06851
        • Cardiology Associates of Fairfield County, PC
    • Florida
      • Boca Raton, Florida, United States, 33422
        • Cardiac Arrhythmia Services
      • Jacksonville, Florida, United States, 32209
        • Shands Jacksonville
      • Lake Mary, Florida, United States, 32746
        • Jorge Diaz, M.D., P.A.
      • Naples, Florida, United States, 34119
        • Naples Heart Rhythm Specialists, PA
      • Ocala, Florida, United States, 34474
        • Central Florida Heart Center
      • Pensacola, Florida, United States, 32501
        • Cardiology Consultants - Baptist Campus
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30309
        • Piedmont Heart Institute - Buckhead Location
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnett Medical Center
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Southeastern Cardiovascular Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60631
        • North Shore Cardiology
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Mid-America Cardiology Associates, PC
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • King's Daughters Medical Center
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • Medstar Health Research Institute
      • Rockville, Maryland, United States, 20850
        • Cardiac Associates PC
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Pioneer Valley Cardiology
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48236
        • St. John Hospital and Medical Center
      • Lansing, Michigan, United States, 48912
        • Thoracic Cardio Healthcare Found. (aka Sparrow Clinical Research Institute)
      • Saginaw, Michigan, United States, 48601
        • Ascension St. Mary's Research Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Nevada
      • Reno, Nevada, United States, 89503
        • Renown Institute for Heart and Vascular Health
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
      • Morristown, New Jersey, United States, 07962
        • Morristown Memorial Hospital (Atlantic Health System)
      • West Orange, New Jersey, United States, 07052
        • New Jersey Cardiology Associates
    • New York
      • Buffalo, New York, United States, 14215
        • Trinity Medical WNY, PC
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
      • New York, New York, United States, 10028
        • Manhattan Cardiac Arrhythmia Consultants
      • Rochester, New York, United States, 14618
        • Westfall Cardiology LLP
    • Ohio
      • Akron, Ohio, United States, 44304
        • Northeast Ohio Cardiovascular Specialists
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Toledo, Ohio, United States, 43615
        • Northwest Ohio Cardiology Consultants
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16502
        • Saint Vincent Consultants in Cardiovascular Diseases
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Singer Research Institute
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Lexington Cardiology
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Medical Center
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Apex Cardiology
      • Memphis, Tennessee, United States, 38104
        • Memphis Cardiac Care Center
      • Nashville, Tennessee, United States, 37205
        • The Heart Group, PLLC
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Page-Campbell Heart Institute
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Heart Group
      • Humble, Texas, United States, 77338
        • Cardiovascular Association, P.L.L.C.
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital
      • Tyler, Texas, United States, 75701
        • Cardiovascular Associates of East Texas
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Medicine School of University Health Care
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Medical Center
      • Midlothian, Virginia, United States, 23224
        • Cardiovascular Associates of Virginia
    • Washington
      • Kirkland, Washington, United States, 98034
        • Eastside Cardiology Associates
      • Spokane, Washington, United States, 99204
        • Kootenai Heart Clinics
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Dr. Edmundo Figueroa, MD
      • Morgantown, West Virginia, United States, 26505
        • Cardiac & Vascular of Monongalia General Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Dean Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardiac Rhythm Management device
Implanted with implantable defibrillator or pacemaker system
Device: Cardiac Rhythm Management device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event Free Survival
Time Frame: 5 year average
5 year average

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Grant Kim, Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2007

Primary Completion (Actual)

July 10, 2020

Study Completion (Actual)

July 10, 2020

Study Registration Dates

First Submitted

December 13, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (Estimate)

December 21, 2012

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

May 7, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40007941/F

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bradycardia

Clinical Trials on Cardiac Rhythm Management device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe