Safety and Efficacy Study of Tendril MRI™ Leads in Standard Bradycardia Pacing Indication

standard bradycardia indications

Inclusion Criteria:

• 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 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 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