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Completed

NCT Number: NCT01258218

Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

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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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Graz, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implantation of an Accent MRI device

Device

Implantation of an Accent MRI device

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 10, 2010
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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