ProMRI Study of the Iforia ICD System (Phase C)

Completed

Conditions studied: Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging

In brief

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

Key facts

Study ID

NCT02096692

Run by

Biotronik, Inc.

People needed

154

Starts

2014-06-01

Expected to finish

2015-06-01

Last updated by the study team

2016-02-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Concord, California, United States
• Study site — Newport Beach, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — New Haven, Connecticut, United States
• Study site — Newark, Delaware, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Valparasio, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Lafayette, Louisiana, United States
• Study site — Cumberland, Maryland, United States
• Study site — Takoma Park, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Ypsilanti, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Flushing, New York, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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