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OpenTrials
Completed

NCT Number: NCT01754064

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

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.

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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Disease Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center Research, LLC., Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac Rhythm Management device

Device

Primary outcomes

  1. Event Free Survival

    Time frame: 5 year average

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2007
Primary completion
2020
Study completion
2020
First posted
Dec 21, 2012
Registry last updated
May 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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