Clinical Trial: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II

Brief Summary: The purpose of this study is to characterize the utilization of diagnostics capabilities in St. Jude Medical pacemakers to manage patients with a standard bradycardia pacing indication.

Detailed Summary:
Sponsor: St. Jude Medical

Current Primary Outcome: Complication rate in general pacemaker population [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of pacemakers patients programmed with advanced pacemaker features [ Time Frame: 1 year ]
    Advanced pacemaker features include Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features.
  • Proportion of pacemakers patients with AT/AF, VT/VF, PMT and AMS episodes [ Time Frame: 1 year ]
    Episodes of AT/AF, VT/VF, PMT and AMS will be measured by the pacemakers diagnostics features.
  • Number of MRI scans received in pacemaker patients by country [ Time Frame: 1 year ]
  • Proportion of MRI scans received in pacemaker patients by country [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: St. Jude Medical

Dates:
Date Received: October 6, 2015
Date Started: July 2015
Date Completion: December 2017
Last Updated: May 18, 2016
Last Verified: May 2016