Status:
COMPLETED
Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment
Lead Sponsor:
Abbott Medical Devices
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
Brief Summary
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 Ten...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01258218
Start Date
February 1 2011
End Date
November 1 2011
Last Update
February 4 2019
Active Locations (1)
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1
Graz, Austria