ProMRI Study of the Entovis Pacemaker System (Phase B)

Completed

Interventions: Device: Patients with a ProMRI Pacemaker System
Other: Magnetic Resonance Imaging (MRI) scan

Brief Summary: The objective of the ProMRI Study (Phase B) is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions without scan exclusion zone.

Recruitment & Eligibility

Inclusion Criteria

The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:

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

Exclusion Criteria

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:

Arm && Interventions

Group	Intervention	Description
Pacemaker Therapy	Magnetic Resonance Imaging (MRI) scan	Patients with a ProMRI Pacemaker System
Pacemaker Therapy	Patients with a ProMRI Pacemaker System	Patients with a ProMRI Pacemaker System

Primary Outcome Measures

Name	Time	Method
MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate	1 Month Post-MRI
Percentage of Participants Free of Atrial Pacing Threshold Rise	Between Pre-MRI and 1 Month Post-MRI	Evaluate the percentage of atrial pacing leads with a pacing threshold increaess between the Pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of Ventricular Pacing Threshold Rise	Between Pre-MRI and 1 Month Post-MRI	Evaluate the percentage of ventricular pacing leads with a pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of P-wave Sensing Attenuation	Between Pre-MRI and 1 Month Post-MRI	Evaluate the percentage of subjects who experience P-wave attenuation between the pre-MRI and one-month post-MRI follow-up.
Percentage of Participants Free of R-wave Sensing Attenuation	Between Pre-MRI and 1 Month Post-MRI	Evaluate the percentage of subjects who experience R-wave attenuation between the pre-MRI and one-month post-MRI follow-up.