Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II (BRADYCARE II)
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|ClinicalTrials.gov Identifier: NCT02577887|
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : November 18, 2019
Last Update Posted : March 9, 2020
|Condition or disease||Intervention/treatment|
|Standard Bradycardia Pacing Indication||Device: Patients implanted with a St. Jude Medical pacemakers|
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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||2101 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Advanced Bradycardia Device Feature Utilization and Clinical Outcomes II|
|Study Start Date :||July 2015|
|Actual Primary Completion Date :||November 25, 2017|
|Actual Study Completion Date :||December 15, 2017|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577887
|114 Avenue d'Arès|
|Bordeaux, France, 33074|
|Kliniken der Friedrich-Alexander-Universität|
|Erlangen, Germany, 91054|
|Via Palermo 636|
|Catania, Italy, 951200|
|Suita, Japan, 565-0871|
|Study Director:||Grant Kim||Abbott Medical Devices|