St. Jude Medical Product Longevity and Performance (SCORE) Registry
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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 :
Completed
First Posted : December 21, 2012
Last Update Posted : January 14, 2021
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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 |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | St. Jude Medical Product Longevity and Performance (SCORE) Registry |
Actual Study Start Date : | November 2007 |
Actual Primary Completion Date : | July 10, 2020 |
Actual Study Completion Date : | July 10, 2020 |
Group/Cohort | Intervention/treatment |
---|---|
Cardiac Rhythm Management device
Implanted with implantable defibrillator or pacemaker system
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Device: Cardiac Rhythm Management device |
- Event Free Survival [ Time Frame: 5 year average ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

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 |
Responsible Party: | Abbott Medical Devices |
ClinicalTrials.gov Identifier: | NCT01754064 |
Other Study ID Numbers: |
40007941/F |
First Posted: | December 21, 2012 Key Record Dates |
Last Update Posted: | January 14, 2021 |
Last Verified: | January 2021 |
Bradycardia Tachycardia Arrhythmia |
ICD pacemaker pacing lead |
Heart Diseases Tachycardia Bradycardia Cardiovascular Diseases |
Arrhythmias, Cardiac Cardiac Conduction System Disease Pathologic Processes |