- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02096692
ProMRI Study of the Iforia ICD System (Phase C)
February 1, 2016 updated by: Biotronik, Inc.
The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
154
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
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Arizona
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Phoenix, Arizona, United States, 85018
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Scottsdale, Arizona, United States, 85251
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California
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Concord, California, United States, 94520
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Newport Beach, California, United States, 92663
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Rancho Mirage, California, United States, 92270
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Connecticut
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New Haven, Connecticut, United States, 06510
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Delaware
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Newark, Delaware, United States, 19702
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District of Columbia
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Washington, District of Columbia, United States, 20010
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Indiana
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Valparasio, Indiana, United States, 46383
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Iowa
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Iowa City, Iowa, United States, 52242
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Louisiana
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Lafayette, Louisiana, United States, 70503
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Maryland
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Cumberland, Maryland, United States, 21502
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Takoma, Maryland, United States, 20912
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Massachusetts
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Boston, Massachusetts, United States, 02114
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Burlington, Massachusetts, United States, 01805
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Worcester, Massachusetts, United States, 01655
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Michigan
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Ann Arbor, Michigan, United States, 48109
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Grand Rapids, Michigan, United States, 49506
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Ypsilanti, Michigan, United States, 48197
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Missouri
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Kansas City, Missouri, United States, 94520
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St. Louis, Missouri, United States, 63110
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New York
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Bronx, New York, United States, 10463
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Flushing, New York, United States, 11355
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New York, New York, United States, 10016
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New York, New York, United States, 10021
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North Carolina
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Winston Salem, North Carolina, United States, 27157
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Ohio
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Columbus, Ohio, United States, 43210
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Toledo, Ohio, United States, 43615
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Oregon
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Portland, Oregon, United States, 97225
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Salem, Oregon, United States, 97301
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Pennsylvania
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Langhorne, Pennsylvania, United States, 08691
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Wynnewood, Pennsylvania, United States, 19096
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South Carolina
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Greenville, South Carolina, United States, 29615
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Tennessee
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Nashville, Tennessee, United States, 37232
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Texas
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Amarillo, Texas, United States, 79106
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Virginia
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Mechanicsville, Virginia, United States, 23116
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Virginia Beach, Virginia, United States, 23454
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Washington
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Spokane, Washington, United States, 99204
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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ICD System Therapy
Patients with a ProMRI ICD System
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Tachycardia Fast Heart Beat
MRI scan of heart/chest or thoracic spine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate
Time Frame: 1 Month Post-MRI
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1 Month Post-MRI
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Percentage of Participants Free of Ventricular Pacing Threshold Rise
Time Frame: Between Pre-MRI and 1 Month Post-MRI
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Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
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Between Pre-MRI and 1 Month Post-MRI
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Percentage of Participants Free of R-wave Sensing Attenuation
Time Frame: Between Pre-MRI and 1 Month Post-MRI
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Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.
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Between Pre-MRI and 1 Month Post-MRI
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
March 24, 2014
First Submitted That Met QC Criteria
March 25, 2014
First Posted (Estimate)
March 26, 2014
Study Record Updates
Last Update Posted (Estimate)
February 29, 2016
Last Update Submitted That Met QC Criteria
February 1, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- G120226 (Phase C)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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