N/A
Completed N=154
ProMRI Study of the Iforia ICD System (Phase C)
Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging
Source: ClinicalTrials.gov NCT02096692 ↗
Enrolled (actual)
154
Serious AEs
14.9%
Results posted
Oct 2015
Primary outcomePrimary: MRI and ICD 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 ICD System when used under specific MRI conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate |
100 | — |
| PRIMARY Percentage of Participants Free of Ventricular Pacing Threshold Rise |
100 | — |
| PRIMARY Percentage of Participants Free of R-wave Sensing Attenuation |
99.3 | — |
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 or equal to 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 an ICD System consisting only of an Iforia DR-T and Linoxsmart S 65 / Linoxsmart SD 65/18 with Setrox S 53 atrial lead or Iforia VR-T DX and Linoxsmart S DX 65/15 or Linoxsmart S DX 65/17.
- ICD implanted pectorally
- All ICD system components implanted, repositioned, or exchanged at least 5 weeks prior to enrollment
- Underlying rhythm identifiable during sensing test
- All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX)
- Ventricular sensing is measurable and >6.5mV
- Absence of phrenic nerve stimulation at 5.0V and 1.0 ms
- Pacing impedance is between 200 and 1500 ohm
- Shock Impedance is between 30 and 90 ohm
- Able and willing to use the CardioMessenger II
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 5.0V @ 1.0 ms
- |pacing threshold at Pre-MRI follow-up - pacing threshold at baseline| ≤ 0.5 V (ICD Lead Only)
- All pacing thresholds are measureable and are less than or equal to 2.0 V @ 0.4 ms (Criterion does not apply to atrial pacing threshold for subjects with an Iforia DR-T that have AF and are permanently programmed to VVI and for subjects with an Iforia VR-T DX.)
- Ventricular sensing is measurable and >6.5mV
- The ICD system has been implanted for at least six weeks.
- Subject did not have an ICD or lead explant, exchange or reposition in the previous 6 weeks.
- All lead pacing impedances are between 200 and 1500 ohm
- Shock impedance is between 30 and 90 ohm
- Battery status is at least 30% of capacity
Data sourced from ClinicalTrials.gov (NCT02096692). 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.