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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cardiac Rhythm Management device
Implanted with implantable defibrillator or pacemaker system
Device: Cardiac Rhythm Management device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings