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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02577887
Study type Observational [Patient Registry]
Source Abbott Medical Devices
Contact
Status Completed
Phase
Start date July 2015
Completion date December 15, 2017