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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01754064
First received: December 13, 2012
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

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 Intervention
Bradycardia
Tachycardia
Heart Disease
Device: Cardiac Rhythm Management device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: St. Jude Medical Product Longevity and Performance (SCORE) Registry

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Event Free Survival [ Time Frame: 5 year average ] [ Designated as safety issue: Yes ]

Enrollment: 10957
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)
Groups/Cohorts Assigned Interventions
Cardiac Rhythm Management device
Implanted with implantable defibrillator or pacemaker system
Device: Cardiac Rhythm Management device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754064

Sponsors and Collaborators
St. Jude Medical
Investigators
Study Director: Ashish Oza St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01754064     History of Changes
Other Study ID Numbers: CRD 366
Study First Received: December 13, 2012
Last Updated: August 27, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014