Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II


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.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 25, 2017

Detailed Description

The study is a prospective, non-randomized, multi-center observational study designed to evaluate the utilization of diagnostic capabilities, indications, MRI scanning capabilities and clinical outcomes of patients implanted with SJM pacemakers. The total duration of the study is expected to be approximately 30 months. The clinical study will be conducted in up to 160 centers across Europe, Middle East, Africa, (EMEA region) and Asia, Australia and New Zealand (Asia-Pac region). Approximately 2016 subjects will be enrolled in this study. Subjects will be followed for 1 year after pacemaker implant.


  • Device: Patients implanted with a St. Jude Medical pacemakers

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Complications in the General Pacemaker Population
    • Time Frame: 1 year
    • The rate of device related adverse events that require a medical intervention and/or hospitalization for treatment.

Secondary Measures

  • Number of Subjects 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.
  • Number of Pacemaker Patients With Atrial Tachycardia/Fibrillation (AT/AF), Ventricular Tachycardia/Fibrillation (VT/VF), Pacemaker-mediated Tachycardia (PMT) and Automatic Mode Switching (AMS) Episodes
    • Time Frame: 1 year
    • At each follow-up, devices were interrogated and device session records were uploaded. Episodes of AT/AF, VT/VF, PMT and AMS were measured by the pacemakers diagnostics features.
  • Number of MRI Scans by Country
    • Time Frame: 1 year
    • The total number of scans performed by country

Participating in This Clinical Trial

Inclusion Criteria

  • Patients who have been implanted with an SJM Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the EMEA region within 30 days or patients implanted with an Accent MRI™, Assurity MRI™, Endurity MRI™ or other SJM MRI compatible pacemakers in the Asia-Pac region within 30 days. – Patient is geographically stable and willing to comply with the required follow-up schedule. – Patient is not pregnant or planning to become pregnant during the course of the study. – Patient is > 18 years of age Exclusion Criteria:

  • Patient's life expectancy is less than 1 year

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Abbott Medical Devices
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Grant Kim, Study Director, Abbott Medical Devices

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.