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

NCT ID: NCT01754064

Last Updated: 2021-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10957 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2020-07-10

Brief Summary

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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.

Detailed Description

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Conditions

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Bradycardia Tachycardia Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Rhythm Management device

Implanted with implantable defibrillator or pacemaker system

Cardiac Rhythm Management device

Intervention Type DEVICE

Interventions

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Cardiac Rhythm Management device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Grant Kim

Role: STUDY_DIRECTOR

Abbott Medical Devices

Locations

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Heart Center Research, LLC.

Huntsville, Alabama, United States

Site Status

Cardiology Associates of Mobile, Inc.

Mobile, Alabama, United States

Site Status

Alaska Heart Institute

Anchorage, Alaska, United States

Site Status

Arizona Cardiovascular Research Center

Phoenix, Arizona, United States

Site Status

Arizona Arrhythmia Consultants

Scottsdale, Arizona, United States

Site Status

Pima Heart Physicians, PC

Tucson, Arizona, United States

Site Status

Northwest Cardiology

Springdale, Arkansas, United States

Site Status

Raymond Schaerf, MD

Burbank, California, United States

Site Status

California Heart Medical Associates

Fresno, California, United States

Site Status

Glendale Memorial Hospital and Medical Center

Glendale, California, United States

Site Status

Jeffrey Goodman MD

Los Angeles, California, United States

Site Status

Cardiac Rhythm Specialists, Inc.

Reseda, California, United States

Site Status

Truong Duong MD

Riverside, California, United States

Site Status

Mercy Medical Group - Cardiology

Sacramento, California, United States

Site Status

Pacific Heart Institute

Santa Monica, California, United States

Site Status

South Denver Cardiology Associates PC

Littleton, Colorado, United States

Site Status

Michael Pittaro MD

New Canaan, Connecticut, United States

Site Status

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, United States

Site Status

Cardiac Arrhythmia Services

Boca Raton, Florida, United States

Site Status

Shands Jacksonville

Jacksonville, Florida, United States

Site Status

Jorge Diaz, M.D., P.A.

Lake Mary, Florida, United States

Site Status

Naples Heart Rhythm Specialists, PA

Naples, Florida, United States

Site Status

Central Florida Heart Center

Ocala, Florida, United States

Site Status

Cardiology Consultants - Baptist Campus

Pensacola, Florida, United States

Site Status

Tallahassee Research Institute

Tallahassee, Florida, United States

Site Status

Piedmont Heart Institute - Buckhead Location

Atlanta, Georgia, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Gwinnett Medical Center

Lawrenceville, Georgia, United States

Site Status

Harbin Clinic Southeastern Cardiovascular Institute

Rome, Georgia, United States

Site Status

North Shore Cardiology

Chicago, Illinois, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Parkview Research Center

Fort Wayne, Indiana, United States

Site Status

Iowa Heart Center

West Des Moines, Iowa, United States

Site Status

Mid-America Cardiology Associates, PC

Kansas City, Kansas, United States

Site Status

King's Daughters Medical Center

Ashland, Kentucky, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

MedStar Health Research Institute

Hyattsville, Maryland, United States

Site Status

Cardiac Associates PC

Rockville, Maryland, United States

Site Status

Pioneer Valley Cardiology

Springfield, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

St. John Hospital and Medical Center

Detroit, Michigan, United States

Site Status

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

Lansing, Michigan, United States

Site Status

Ascension St. Mary's Research Institute

Saginaw, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Renown Institute for Heart and Vascular Health

Reno, Nevada, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Catholic Medical Center

Manchester, New Hampshire, United States

Site Status

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Site Status

Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Site Status

Morristown Memorial Hospital (Atlantic Health System)

Morristown, New Jersey, United States

Site Status

New Jersey Cardiology Associates

West Orange, New Jersey, United States

Site Status

Trinity Medical WNY, PC

Buffalo, New York, United States

Site Status

Manhattan Cardiac Arrhythmia Consultants

New York, New York, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

Westfall Cardiology LLP

Rochester, New York, United States

Site Status

Northeast Ohio Cardiovascular Specialists

Akron, Ohio, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Northwest Ohio Cardiology Consultants

Toledo, Ohio, United States

Site Status

Saint Vincent Consultants in Cardiovascular Diseases

Erie, Pennsylvania, United States

Site Status

Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Site Status

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, United States

Site Status

Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, United States

Site Status

Lexington Cardiology

Columbia, South Carolina, United States

Site Status

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Site Status

Apex Cardiology

Jackson, Tennessee, United States

Site Status

Memphis Cardiac Care Center

Memphis, Tennessee, United States

Site Status

The Heart Group, PLLC

Nashville, Tennessee, United States

Site Status

Vanderbilt Page-Campbell Heart Institute

Nashville, Tennessee, United States

Site Status

Dallas Heart Group

Dallas, Texas, United States

Site Status

Cardiovascular Association, P.L.L.C.

Humble, Texas, United States

Site Status

Scott & White Memorial Hospital

Temple, Texas, United States

Site Status

Cardiovascular Associates of East Texas

Tyler, Texas, United States

Site Status

Medicine School of University Health Care

Salt Lake City, Utah, United States

Site Status

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status

Cardiovascular Associates of Virginia

Midlothian, Virginia, United States

Site Status

Eastside Cardiology Associates

Kirkland, Washington, United States

Site Status

Kootenai Heart Clinics

Spokane, Washington, United States

Site Status

Dr. Edmundo Figueroa, MD

Charleston, West Virginia, United States

Site Status

Cardiac & Vascular of Monongalia General Hospital

Morgantown, West Virginia, United States

Site Status

Dean Foundation

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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40007941/F

Identifier Type: -

Identifier Source: org_study_id

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