Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
154 participants
OBSERVATIONAL
2014-06-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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ICD System Therapy
Patients with a ProMRI ICD System
Patients with a ProMRI ICD System
Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI) scan
MRI scan of heart/chest or thoracic spine
Interventions
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Patients with a ProMRI ICD System
Tachycardia Fast Heart Beat
Magnetic Resonance Imaging (MRI) scan
MRI scan of heart/chest or thoracic spine
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Biotronik, Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Concord, California, United States
Newport Beach, California, United States
Rancho Mirage, California, United States
New Haven, Connecticut, United States
Newark, Delaware, United States
Washington D.C., District of Columbia, United States
Valparasio, Indiana, United States
Iowa City, Iowa, United States
Lafayette, Louisiana, United States
Cumberland, Maryland, United States
Takoma Park, Maryland, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Ypsilanti, Michigan, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Flushing, New York, United States
New York, New York, United States
New York, New York, United States
The Bronx, New York, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
Portland, Oregon, United States
Salem, Oregon, United States
Langhorne, Pennsylvania, United States
Wynnewood, Pennsylvania, United States
Greenville, South Carolina, United States
Nashville, Tennessee, United States
Amarillo, Texas, United States
Mechanicsville, Virginia, United States
Virginia Beach, Virginia, United States
Spokane, Washington, United States
Countries
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References
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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.
Other Identifiers
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G120226 (Phase C)
Identifier Type: -
Identifier Source: org_study_id