St. Jude Medical Product Longevity and Performance (SCORE) Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01754064|
Recruitment Status : Active, not recruiting
First Posted : December 21, 2012
Last Update Posted : February 28, 2020
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.
|Condition or disease||Intervention/treatment|
|Bradycardia Tachycardia Heart Disease||Device: Cardiac Rhythm Management device|
|Study Type :||Observational|
|Actual Enrollment :||10957 participants|
|Official Title:||St. Jude Medical Product Longevity and Performance (SCORE) Registry|
|Actual Study Start Date :||November 2007|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Cardiac Rhythm Management device
Implanted with implantable defibrillator or pacemaker system
Device: Cardiac Rhythm Management device
- Event Free Survival [ Time Frame: 5 year average ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754064
|Study Director:||Grant Kim||Abbott Medical Devices|