NCT01754064

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,957

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

Geographic Reach
1 country

80 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

12.7 years

First QC Date

December 13, 2012

Last Update Submit

May 7, 2021

Conditions

Keywords

BradycardiaTachycardiaArrhythmiaICDpacemakerpacing lead

Outcome Measures

Primary Outcomes (1)

  • Event Free Survival

    5 year average

Study Arms (1)

Cardiac Rhythm Management device

Implanted with implantable defibrillator or pacemaker system

Device: Cardiac Rhythm Management device

Interventions

Cardiac Rhythm Management device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (80)

Heart Center Research, LLC.

Huntsville, Alabama, 35801, United States

Location

Cardiology Associates of Mobile, Inc.

Mobile, Alabama, 36608, United States

Location

Alaska Heart Institute

Anchorage, Alaska, 99508, United States

Location

Arizona Cardiovascular Research Center

Phoenix, Arizona, 85016, United States

Location

Arizona Arrhythmia Consultants

Scottsdale, Arizona, 85251, United States

Location

Pima Heart Physicians, PC

Tucson, Arizona, 85712, United States

Location

Northwest Cardiology

Springdale, Arkansas, 72764, United States

Location

Raymond Schaerf, MD

Burbank, California, 91505, United States

Location

California Heart Medical Associates

Fresno, California, 93720, United States

Location

Glendale Memorial Hospital and Medical Center

Glendale, California, 91204-2508, United States

Location

Jeffrey Goodman MD

Los Angeles, California, 90048, United States

Location

Cardiac Rhythm Specialists, Inc.

Reseda, California, 91335, United States

Location

Truong Duong MD

Riverside, California, 92501, United States

Location

Mercy Medical Group - Cardiology

Sacramento, California, 95819, United States

Location

Pacific Heart Institute

Santa Monica, California, 90404, United States

Location

South Denver Cardiology Associates PC

Littleton, Colorado, 80120, United States

Location

Michael Pittaro MD

New Canaan, Connecticut, 06840, United States

Location

Cardiology Associates of Fairfield County, PC

Norwalk, Connecticut, 06851, United States

Location

Cardiac Arrhythmia Services

Boca Raton, Florida, 33422, United States

Location

Shands Jacksonville

Jacksonville, Florida, 32209, United States

Location

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

Lake Mary, Florida, 32746, United States

Location

Naples Heart Rhythm Specialists, PA

Naples, Florida, 34119, United States

Location

Central Florida Heart Center

Ocala, Florida, 34474, United States

Location

Cardiology Consultants - Baptist Campus

Pensacola, Florida, 32501, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Piedmont Heart Institute - Buckhead Location

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

Harbin Clinic Southeastern Cardiovascular Institute

Rome, Georgia, 30165, United States

Location

North Shore Cardiology

Chicago, Illinois, 60631, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Parkview Research Center

Fort Wayne, Indiana, 46845, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Mid-America Cardiology Associates, PC

Kansas City, Kansas, 66160, United States

Location

King's Daughters Medical Center

Ashland, Kentucky, 41101, United States

Location

Baptist Health Lexington

Lexington, Kentucky, 40503, United States

Location

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

Location

Cardiac Associates PC

Rockville, Maryland, 20850, United States

Location

Pioneer Valley Cardiology

Springfield, Massachusetts, 01107, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

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

Lansing, Michigan, 48912, United States

Location

Ascension St. Mary's Research Institute

Saginaw, Michigan, 48601, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Renown Institute for Heart and Vascular Health

Reno, Nevada, 89503, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, United States

Location

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

Morristown Memorial Hospital (Atlantic Health System)

Morristown, New Jersey, 07962, United States

Location

New Jersey Cardiology Associates

West Orange, New Jersey, 07052, United States

Location

Trinity Medical WNY, PC

Buffalo, New York, 14215, United States

Location

Manhattan Cardiac Arrhythmia Consultants

New York, New York, 10028, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Westfall Cardiology LLP

Rochester, New York, 14618, United States

Location

Northeast Ohio Cardiovascular Specialists

Akron, Ohio, 44304, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Northwest Ohio Cardiology Consultants

Toledo, Ohio, 43615, United States

Location

Saint Vincent Consultants in Cardiovascular Diseases

Erie, Pennsylvania, 16502, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Allegheny Singer Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, 19067, United States

Location

Lexington Cardiology

Columbia, South Carolina, 29204, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Apex Cardiology

Jackson, Tennessee, 38301, United States

Location

Memphis Cardiac Care Center

Memphis, Tennessee, 38104, United States

Location

The Heart Group, PLLC

Nashville, Tennessee, 37205, United States

Location

Vanderbilt Page-Campbell Heart Institute

Nashville, Tennessee, 37232, United States

Location

Dallas Heart Group

Dallas, Texas, 75230, United States

Location

Cardiovascular Association, P.L.L.C.

Humble, Texas, 77338, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

Medicine School of University Health Care

Salt Lake City, Utah, 84132, United States

Location

University of Virginia Medical Center

Charlottesville, Virginia, 22908, United States

Location

Cardiovascular Associates of Virginia

Midlothian, Virginia, 23224, United States

Location

Eastside Cardiology Associates

Kirkland, Washington, 98034, United States

Location

Kootenai Heart Clinics

Spokane, Washington, 99204, United States

Location

Dr. Edmundo Figueroa, MD

Charleston, West Virginia, 25301, United States

Location

Cardiac & Vascular of Monongalia General Hospital

Morgantown, West Virginia, 26505, United States

Location

Dean Foundation

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

BradycardiaTachycardiaHeart DiseasesArrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiac Conduction System Disease

Study Officials

  • Grant Kim

    Abbott Medical Devices

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2012

First Posted

December 21, 2012

Study Start

November 1, 2007

Primary Completion

July 10, 2020

Study Completion

July 10, 2020

Last Updated

May 11, 2021

Record last verified: 2021-05

Locations