Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II (BRADYCARE II)

Abbott

Status: Completed

Conditions: Standard Bradycardia Pacing Indication

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02577887

SJM-CIP-10073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design