N/A
Completed N=229
ProMRI Study of the Entovis Pacemaker System
Safety of the ProMRI Pacemaker System Under Specific MRI Conditions
Source: ClinicalTrials.gov NCT01761162 ↗
Enrolled (actual)
229
Serious AEs
9.2%
Results posted
Nov 2014
Primary outcomePrimary: MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate — 100 percentage of participants
Summary
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI Pacemaker System when used under specific MRI conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MRI and Pacing System Related Serious Adverse Device Effect (SADE) Free Rate |
100 | — |
| PRIMARY Percentage of Participants Free of Atrial Pacing Threshold Rise |
99.0 | — |
| PRIMARY Percentage of Participants Free of Ventricular Pacing Threshold Rise |
100 | — |
| PRIMARY Percentage of Participants Free of P-wave Sensing Attenuation |
99.4 | — |
| PRIMARY Percentage of Participants Free of R-wave Sensing Attenuation |
99.5 | — |
Eligibility Criteria
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
- 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
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:
- 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
Data sourced from ClinicalTrials.gov (NCT01761162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.