ProMRI Study of the Entovis Pacemaker System

Inclusion Criteria

• •Age greater than 18 years
• •Subject body height greater than 140 cm (4' 7")
• •Able and willing to complete MRI testing
• •Able to provide written informed consent
• •Available for follow-up visit at the study site
• •Implanted with a pacemaker system consisting only of an Entovis pacemaker (DR-T, SR-T) and one or two Setrox S 53 or Setrox S 60 pacemaker lead(s). (No leads other than Setrox S (53 or 60 cm) leads may be implanted. This includes lead extensions or abandoned leads in the subject.)
• •Pacemaker implanted pectorally
• •All pacemaker system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
• •Underling rhythm identifiable during sensing test
• •All pacing thresholds are measureable and are less than or equal to 2.0 V @0.4 ms
• •Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
• •Pacing impedance is between 200 and 1500 ohm
• •Able and willing to use the Cardio Messenger
• •At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:
• •Absence of phrenic nerve stimulation at 4.8V @ 1.0 ms
• •\|pacing threshold at Pre-MRI follow-up - pacing threshold at baseline\| ≤ 0.5 V
• •All pacing thresholds are measureable and are ≤ 2.0 V @ 0.4 ms
• •The pacemaker system has been implanted for at least 6 weeks.
• •Subject did not have a pacemaker or lead explant, exchange or reposition in the previous 6 weeks.
• •All lead impedances are between 200 and 1500 ohm.
• •Battery status is at least 30% of capacity