Status:
COMPLETED
Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication
Lead Sponsor:
Abbott Medical Devices
Conditions:
Bradycardia
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this observational study is the assessment (safety and efficacy) of the St. Jude Medical Tendril MRI™ leads. The Tendril MRI™ leads are a full part of the Accent MRI™ System, consisting...
Detailed Description
Magnetic resonance imaging (MRI) is a diagnostic method to view high quality two and three dimensional images of the body. However, magnetic resonance imaging systems generate three electromagnetic fi...
Eligibility Criteria
Inclusion
- Approved Class I or Class II indication per: European Society of Cardiology (ESC) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker, OR American College of Cardiology (ACC) / American Heart Association (AHA) / Heart Rhythm Society (HRS) guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker
- Require a new Accent MRI™ pacemaker and Tendril MRI™ lead (either initial implant or complete system change out with no abandoned devices).
- Is ≥ 18 years of age.
- Able to provide written informed consent prior to any investigational related procedure.
- 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 implanted medical device (e.g., Implantable Cardioverter Defibrillator (ICD), neurostimulator, 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, plug or adaptor.
- Have a prosthetic tricuspid heart valve.
- Are currently participating in another investigational device or drug investigation.
- Are allergic to Dexamethasone sodium phosphate (DSP).
- Are pregnant or planning to become pregnant during the duration of the study.
- Have a life expectancy of less than 12 months from Screening due to any life-threatening condition
Key Trial Info
Start Date :
February 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT01528150
Start Date
February 1 2012
End Date
March 1 2015
Last Update
February 4 2019
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.