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Trial record 2 of 2 for:    BRADYCARE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577887
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : November 18, 2019
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Standard Bradycardia Pacing Indication Device: Patients implanted with a St. Jude Medical pacemakers

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2101 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. Number of MRI Scans by Country [ Time Frame: 1 year ]
    The total number of scans performed by country



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a standard bradycardia pacing indication and implanted with a St. Jude Medical pacemaker
Criteria

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

Information from the National Library of Medicine

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


Locations
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France
114 Avenue d'Arès
Bordeaux, France, 33074
Germany
Kliniken der Friedrich-Alexander-Universität
Erlangen, Germany, 91054
Italy
Via Palermo 636
Catania, Italy, 951200
Japan
2-15 Yamadaoka
Suita, Japan, 565-0871
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Grant Kim Abbott Medical Devices
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:

Additional Information:

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02577887    
Other Study ID Numbers: SJM-CIP-10073
First Posted: October 16, 2015    Key Record Dates
Results First Posted: November 18, 2019
Last Update Posted: March 9, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Bradycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes