Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II

Completed

• Conditions: Standard Bradycardia Pacing Indication

• Registration Number: NCT02577887
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-16
• Primary Completion: 2017-11-25
• Study Completion: 2017-12-15
• Results First Submitted: 2019-01-28
• Results First Submitted QC: 2019-10-29
• Results First Posted: 2019-11-18
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Programmed With Advanced Pacemaker Features	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	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	1 year	The total number of scans performed by country

Trial Locations

Locations (4)

Via Palermo 636; 🇮🇹 Catania, Italy

114 Avenue d'Arès; 🇫🇷 Bordeaux, France

Kliniken der Friedrich-Alexander-Universität; 🇩🇪 Erlangen, Germany

2-15 Yamadaoka; 🇯🇵 Suita, Japan