Bradycardia, Heart Disease, Tachycardia
Conditions
Keywords
Bradycardia, Tachycardia, Arrhythmia, ICD, pacemaker, pacing lead
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.
Interventions
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event Free Survival | 5 year average |
Countries
United States
Outcome results
None listed