Text Size

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: December 17, 2012
Last verified: December 2012
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases
U.S. FDA Resources

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
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: December 17, 2012
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 May 21, 2013