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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	10957 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	St. Jude Medical Product Longevity and Performance (SCORE) Registry
Study Start Date :	November 2007
Estimated Primary Completion Date :	November 2018
Estimated Study Completion Date :	November 2018

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 71 Study Locations

Sponsors and Collaborators

St. Jude Medical

Investigators

Study Director:	Ashish Oza	St. Jude Medical

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT01754064 History of Changes
Other Study ID Numbers:	CRD 366
First Posted:	December 21, 2012
Last Update Posted:	October 8, 2015
Last Verified:	October 2015

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