Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-24 @ 3:36 PM
NCT ID:
NCT02096692
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02096692
Study Brief:
Protocol Section:
NCT02096692