Accent MRI Pacemaker and Tendril MRI Lead New Technology Assessment

Abbott

Status: Completed

Conditions: Bradycardia

Treatments: Device: Implantation of an Accent MRI device

Study type: Observational

Funder types: Industry

Identifiers

NCT01258218

CR-10-027-EU-LV

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

78 participants in 1 patient group

Accent MRI Group

Treatment:

Device: Implantation of an Accent MRI device