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

Abbott Medical Devices10,957 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

10,957

Conditions

Bradycardia Tachycardia Heart Disease

Interventions

Cardiac Rhythm Management deviceDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Event Free Survival

Time frame: 5 year average

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 70 more locations