Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II

Study Overview
=================
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 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.

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

Conditions
-----------------
Standard Bradycardia Pacing Indication

Intervention / Treatment
-----------------
* Device: Patients implanted with a St. Jude Medical pacemakers


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Patients implanted with a St. Jude Medical pacemakers|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Programmed With Advanced Pacemaker Features | Advanced pacemaker features include Autocapture, Auto sensitivity control (ASC), Ventricular Intrinsic Preference (VIP®), Patient Notifier, RF telemetry, and newer advanced features. | 1 year | 
| 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 | 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. | 1 year | 
| Number of MRI Scans by Country | The total number of scans performed by country | 1 year |