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St. Jude Medical Product Longevity and Performance (SCORE) Registry | Clinical Trials | Clareo Health

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

NCT01754064•Abbott Medical Devices

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (80)

Heart Center Research, LLC.

Huntsville, Alabama, United States

Cardiology Associates of Mobile, Inc.

Mobile, Alabama, United States

Alaska Heart Institute

Anchorage, Alaska, United States

Arizona Cardiovascular Research Center

Phoenix, Arizona, United States

Arizona Arrhythmia Consultants

Scottsdale, Arizona, United States

Pima Heart Physicians, PC

Tucson, Arizona, United States

Northwest Cardiology

Springdale, Arkansas, United States

Raymond Schaerf, MD

Burbank, California, United States

California Heart Medical Associates

Fresno, California, United States

Glendale Memorial Hospital and Medical Center

Glendale, California, United States

Key Dates

Start Date

November 1, 2007

Primary Completion Date

July 10, 2020

Completion Date

July 10, 2020

Last Updated

May 11, 2021

Enrollment

10,957

ACTUAL participants

Conditions

BradycardiaTachycardiaHeart Disease

Interventions

Cardiac Rhythm Management device

DEVICE

Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal

NCT06690151

Heart Disease CongenitalNeurodevelopmental Disorder

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RECRUITINGPHASE1

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

NCT05647213

Univentricular HeartCongenital Heart Disease+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Characterization and Support of Neurodevelopmental Disorders Associated With Congenital Cardiac malfoRmations - Neonatal

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

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