Completed

NCT Number: NCT02577887

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.

Completed

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Key information

Conditions

Standard Bradycardia Pacing Indication

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

114 Avenue d'Arès, Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients implanted with a St. Jude Medical pacemakers

Device

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Acronym: BRADYCARE II

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Oct 16, 2015
Registry last updated: Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.