ProMRI Study of the Iforia ICD System (Phase C)



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:June 2014
End Date:June 2015

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The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD
System when used under specific MRI conditions.


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
We found this trial at
39
sites
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Cumberland, MD
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Amarillo, TX
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Concord, CA
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Flushing, NY
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Grand Rapids, MI
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Greenville, South Carolina 29605
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Greenville, SC
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Iowa City, IA
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Mechanicsville, VA
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Newark, DE
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Newport Beach, California 92660
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Phoenix, AZ
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Portland, OR
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Rancho Mirage, California 90070
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Salem, OR
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Washington,
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Winston Salem, North Carolina 27157
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Worcester, MA
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Wynnewood, PA
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Ypsilanti, MI
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