St. Jude Medical Product Longevity and Performance (SCORE) Registry
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.
Device: Cardiac Rhythm Management device
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||St. Jude Medical Product Longevity and Performance (SCORE) Registry|
- Event Free Survival [ Time Frame: 5 year average ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||November 2018|
|Estimated Primary Completion Date:||November 2018 (Final data collection date for primary outcome measure)|
Cardiac Rhythm Management device
Implanted with implantable defibrillator or pacemaker system
|Device: Cardiac Rhythm Management device|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754064
|Study Director:||Ashish Oza||St. Jude Medical|