Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II

Standard Bradycardia Pacing Indication Clinical Trial

— BRADYCARE II  

Official title:

Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577887
• Other study ID #: SJM-CIP-10073
• Status: Completed
• Start date: July 2015
• Est. completion date: December 15, 2017

Study information

• Verified date: February 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2101
• Est. completion date: December 15, 2017
• Est. primary completion date: November 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bradycardia
• Standard Bradycardia Pacing Indication

Intervention

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

Locations

Country	Name	City	State
France	114 Avenue d'Arès	Bordeaux
Germany	Kliniken der Friedrich-Alexander-Universität	Erlangen
Italy	Via Palermo 636	Catania
Japan	2-15 Yamadaoka	Suita

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

France,  Germany,  Italy,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of MRI Scans by Country	The total number of scans performed by country	1 year