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BradycardiaNCT01754064

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

An observational study of Bradycardia and Tachycardia, run by Abbott Medical Devices at 80 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bradycardia, Tachycardia, Heart Disease
What is being tested?
Cardiac Rhythm Management device
Type of treatment
Medical device
How many people
10,957 participants
Where
80 sitesUnited States
Study dates
Nov 2007to 10 Jul 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

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.

Trial locations and contacts

80 sites in 1 country.

80 sites in 1 country

United States80 sites

  • Northeast Ohio Cardiovascular Specialists

    Akron, Ohio, 44304

  • Alaska Heart Institute

    Anchorage, Alaska, 99508

  • King's Daughters Medical Center

    Ashland, Kentucky, 41101

  • Piedmont Heart Institute - Buckhead Location

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Cardiac Arrhythmia Services

    Boca Raton, Florida, 33422

  • Deborah Heart and Lung Center

    Browns Mills, New Jersey, 08015

  • Trinity Medical WNY, PC

    Buffalo, New York, 14215

  • Raymond Schaerf, MD

    Burbank, California, 91505

  • Dr. Edmundo Figueroa, MD

    Charleston, West Virginia, 25301

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

  • North Shore Cardiology

    Chicago, Illinois, 60631

  • University of Chicago

    Chicago, Illinois, 60637

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Lexington Cardiology

    Columbia, South Carolina, 29204

  • Dallas Heart Group

    Dallas, Texas, 75230

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Saint Vincent Consultants in Cardiovascular Diseases

    Erie, Pennsylvania, 16502

  • Parkview Research Center

    Fort Wayne, Indiana, 46845

  • California Heart Medical Associates

    Fresno, California, 93720

  • Glendale Memorial Hospital and Medical Center

    Glendale, California, 91204-2508

  • Cardiovascular Association, P.L.L.C.

    Humble, Texas, 77338

  • Heart Center Research, LLC.

    Huntsville, Alabama, 35801

  • MedStar Health Research Institute

    Hyattsville, Maryland, 20782

  • Apex Cardiology

    Jackson, Tennessee, 38301

  • Shands Jacksonville

    Jacksonville, Florida, 32209

  • Mid-America Cardiology Associates, PC

    Kansas City, Kansas, 66160

  • Eastside Cardiology Associates

    Kirkland, Washington, 98034

  • Jorge Diaz, M.D., P.A.

    Lake Mary, Florida, 32746

  • Thoracic Cardio Healthcare Found. (aka Sparrow Clinical Research Institute)

    Lansing, Michigan, 48912

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • South Denver Cardiology Associates PC

    Littleton, Colorado, 80120

  • Jeffrey Goodman MD

    Los Angeles, California, 90048

  • Dean Foundation

    Madison, Wisconsin, 53715

  • Catholic Medical Center

    Manchester, New Hampshire, 03102

  • Memphis Cardiac Care Center

    Memphis, Tennessee, 38104

  • Cardiovascular Associates of Virginia

    Midlothian, Virginia, 23224

  • Cardiology Associates of Mobile, Inc.

    Mobile, Alabama, 36608

  • Cardiac & Vascular of Monongalia General Hospital

    Morgantown, West Virginia, 26505

  • Morristown Memorial Hospital (Atlantic Health System)

    Morristown, New Jersey, 07962

  • Naples Heart Rhythm Specialists, PA

    Naples, Florida, 34119

  • The Heart Group, PLLC

    Nashville, Tennessee, 37205

  • Vanderbilt Page-Campbell Heart Institute

    Nashville, Tennessee, 37232

  • Michael Pittaro MD

    New Canaan, Connecticut, 06840

  • Manhattan Cardiac Arrhythmia Consultants

    New York, New York, 10028

  • Mount Sinai Hospital

    New York, New York, 10029

  • Cardiology Associates of Fairfield County, PC

    Norwalk, Connecticut, 06851

  • Central Florida Heart Center

    Ocala, Florida, 34474

  • Cardiology Consultants - Baptist Campus

    Pensacola, Florida, 32501

  • Drexel University College of Medicine

    Philadelphia, Pennsylvania, 19102

  • Arizona Cardiovascular Research Center

    Phoenix, Arizona, 85016

  • Allegheny Singer Research Institute

    Pittsburgh, Pennsylvania, 15212

  • Renown Institute for Heart and Vascular Health

    Reno, Nevada, 89503

  • Cardiac Rhythm Specialists, Inc.

    Reseda, California, 91335

  • Truong Duong MD

    Riverside, California, 92501

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Westfall Cardiology LLP

    Rochester, New York, 14618

  • Cardiac Associates PC

    Rockville, Maryland, 20850

  • Harbin Clinic Southeastern Cardiovascular Institute

    Rome, Georgia, 30165

  • Mercy Medical Group - Cardiology

    Sacramento, California, 95819

  • Ascension St. Mary's Research Institute

    Saginaw, Michigan, 48601

  • Medicine School of University Health Care

    Salt Lake City, Utah, 84132

  • Pacific Heart Institute

    Santa Monica, California, 90404

  • Arizona Arrhythmia Consultants

    Scottsdale, Arizona, 85251

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Kootenai Heart Clinics

    Spokane, Washington, 99204

  • Northwest Cardiology

    Springdale, Arkansas, 72764

  • Pioneer Valley Cardiology

    Springfield, Massachusetts, 01107

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

  • Scott & White Memorial Hospital

    Temple, Texas, 76508

  • Northwest Ohio Cardiology Consultants

    Toledo, Ohio, 43615

  • Pima Heart Physicians, PC

    Tucson, Arizona, 85712

  • Cardiovascular Associates of East Texas

    Tyler, Texas, 75701

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • New Jersey Cardiology Associates

    West Orange, New Jersey, 07052

  • Cardiology Consultants of Philadelphia

    Yardley, Pennsylvania, 19067

Other trials in United States

About this study

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.

Being tested
Cardiac Rhythm Management device
Keywords
Bradycardia, Tachycardia, Arrhythmia, ICD, pacemaker, pacing lead
Medical subject headings
Bradycardia, Tachycardia, Heart Diseases, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac Rhythm Management deviceDevice

Study groups in NCT01754064
Study groupRoleWhat they receive
Cardiac Rhythm Management deviceImplanted with implantable defibrillator or pacemaker system
Receives: Device: Cardiac Rhythm Management device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival

    Measured: 5 year average

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2012 (estimated)
  2. Study startNov 2007
  3. Primary completion10 Jul 2020
  4. Study completion10 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,957 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01754064
Sponsor's protocol ID
40007941/F
Status last verified
May 2021
First submitted
13 Dec 2012
Last updated
11 May 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Bradycardia and Tachycardia, run by Abbott Medical Devices at 80 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival (time frame: 5 year average). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01754064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.

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