Clinical trial NCT02096692: ProMRI Study of the Iforia ICD System (Phase C)
Official title: ProMRI Study of the Iforia ICD System (Phase C)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implantable Cardioverter-Defibrillator With Magnetic Resonance Imaging
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.

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


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

Primary outcomes:
measure: MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate
timeFrame: 1 Month Post-MRI
measure: Percentage of Participants Free of Ventricular Pacing Threshold Rise
timeFrame: Between Pre-MRI and 1 Month Post-MRI
measure: Percentage of Participants Free of R-wave Sensing Attenuation
timeFrame: Between Pre-MRI and 1 Month Post-MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Concord
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Rancho Mirage
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Washington
country: United States
state: District of Columbia
city: Valparasio
country: United States
state: Indiana
city: Iowa City
country: United States
state: Iowa
city: Lafayette
country: United States
state: Louisiana
city: Cumberland
country: United States
state: Maryland
city: Takoma
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Grand Rapids
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Bronx
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Winston Salem
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Salem
country: United States
state: Oregon
city: Langhorne
country: United States
state: Pennsylvania
city: Wynnewood
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Mechanicsville
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
References:
citation: Awad K, Griffin J, Crawford TC, Lane Cox S, Ferrick K, Mazur A, Pena RE, Lloyd SG, Michalski J, Johnson W, Bailey WM. Clinical safety of the Iforia implantable cardioverter-defibrillator system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions. Heart Rhythm. 2015 Oct;12(10):2155-61. doi: 10.1016/j.hrthm.2015.06.002. Epub 2015 Jun 3.