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CompletedNCT01258218Updated Feb 4, 2019

Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

An observational study in Bradycardia, sponsored by Abbott Medical Devices. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-04.

Sponsored by Abbott Medical Devices · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
78
Ages
18 Years and older
Sex
All
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Study 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 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.

02

Conditions studied

  • Bradycardia

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03

In context

Bradycardia

307 studies on the registry are indexed under Bradycardia; 70 are open to participants now.

This study's enrollment of 78 is below the median of 257 across 129 observational studies indexed under Bradycardia.

Browse Bradycardia studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with approved Class I or Class II indication per ESC guidelines for implantation of a dual chamber pacemaker or single chamber pacemaker.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
78 participants (actual)

Groups and cohorts

  • Accent MRI Group

    Device: Implantation of an Accent MRI device

Interventions

  • DeviceImplantation of an Accent MRI device

    Implantation of an Accent MRI device

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Study locations

1 site
  • Graz, Austria
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01258218
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Dec 10, 2010
Start date
Feb 2011
Primary completion
Nov 2011
Completion
Nov 2011
Last update
Feb 4, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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