Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-11-30

Brief Summary

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The intent of this study is to evaluate the performance of the implanted Accent MRI TM system in a clinical setting and optionally in the MRI environment. This system includes the St. Jude Medical Tendril MRI™ lead and SJM Accent MRITM DR pacemaker. Also the MRI Activator™ will be evaluated in this study. The MRI Activator is a handheld device that allows the user to enable and disable MRI Settings as well as check the status of MRI Settings in the pacemaker. The patient population under study includes patients with a standard bradycardia pacing indication.

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Detailed Description

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Conditions

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Bradycardia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Accent MRI Group

Implantation of an Accent MRI device

Intervention Type DEVICE

Implantation of an Accent MRI device

Interventions

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Implantation of an Accent MRI device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Approved Class I or Class II indication per ESC guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker.
* Receiving a new Accent MRITM pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
* Ability to provide informed consent for study participation.
* Is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

Exclusion Criteria

* Have an existing pacemaker or ICD (abandoned devices and/or leads are not allowed. A new pacemaker and lead or complete system change out is required for enrollment).
* Have an existing active/inactive implanted medical device (e. g., Neurostimulator, infusion pump, etc.).
* Have a non-MRI compatible device or material implant (e.g., intracranial aneurysm clip, non-MRI compatible devices or material, metals or alloys, etc.).
* Have a lead extender or adaptor.
* Have a mechanical, prosthetic or bioprosthetic tricuspid heart valve.
* Have an abdominal diameter (approximately \> 60cm) which results in contact with the magnet façade.
* Are currently participating in a study that includes an active treatment arm.
* Are pregnant or planning to become pregnant during the duration of the study.
* Have a life expectancy of less than 6 months due to any condition.
* Are less than 18 years of age.
* Are unable to comply with the follow up schedule.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No