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

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ClinicalTrials.gov Identifier: NCT01754064
Recruitment Status : Active, not recruiting
First Posted : December 21, 2012
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical

Study Description
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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.


Condition or disease Intervention/treatment
Bradycardia Tachycardia Heart Disease Device: Cardiac Rhythm Management device

Study Design
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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
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020
Groups and Cohorts
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Group/Cohort Intervention/treatment
Cardiac Rhythm Management device
Implanted with implantable defibrillator or pacemaker system
 Device: Cardiac Rhythm Management device


Outcome Measures
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Primary Outcome Measures :
  1. Event Free Survival [ Time Frame: 5 year average ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient indicated for a cardiac rhythm management (CRM) product like ICD, pacemaker, CRT-D, CRT-P, leads, etc. would be eligible for participation in the study.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


  Show 71 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Grant Kim St. Jude Medical
More Information
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Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01754064     History of Changes
Other Study ID Numbers: 40007941/F
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018

Keywords provided by St. Jude Medical:
Bradycardia
Tachycardia
Arrhythimas
 ICD
pacemaker
pacing lead

Additional relevant MeSH terms:
Heart Diseases
Tachycardia
Bradycardia
 Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes