Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biotronik, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age greater than 18 years
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
You may not be if
Enrolled in any other clinical study
For pacemaker systems that include an atrial lead, subjects with either
* Persistent atrial arrhythmia (lasting longer than 7 days or requiring cardioversion)
* Permanent atrial arrhythmia
Life expectancy of less than three months
Pregnancy
Cardiac surgery expected in the next three months
Implanted with other medical devices that may interact with MRI, such as:
abandoned pacemaker/ICD leads
lead extensions
mechanical valves
other active medical devices
non-MRI compatible devices
other metallic artifacts/components in body that may interact with MRI
Clareo Health | ProMRI Study of the Entovis Pacemaker System (Phase B)
