ProMRI Study of the Iforia ICD System (Phase C)
1 other identifier
observational
154
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2014
Shorter than P25 for all trials
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 26, 2014
CompletedStudy Start
First participant enrolled
June 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
October 22, 2015
CompletedFebruary 29, 2016
February 1, 2016
9 months
March 24, 2014
September 18, 2015
February 1, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate
1 Month Post-MRI
Percentage of Participants Free of Ventricular Pacing Threshold Rise
Evaluate the percentage of ICD leads free of ventricular pacing threshold increase between the Pre-MRI and one-month post-MRI follow-up.
Between Pre-MRI and 1 Month Post-MRI
Percentage of Participants Free of R-wave Sensing Attenuation
Evaluate the percentage of subjects free of R-wave attenuation between the Pre-MRI and one-month post-MRI follow-up.
Between Pre-MRI and 1 Month Post-MRI
Study Arms (1)
ICD System Therapy
Patients with a ProMRI ICD System
Interventions
MRI scan of heart/chest or thoracic spine
Eligibility Criteria
The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.
You may qualify if:
- 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:
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biotronik, Inc.lead
Study Sites (39)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Phoenix, Arizona, 85018, United States
Unknown Facility
Scottsdale, Arizona, 85251, United States
Unknown Facility
Concord, California, 94520, United States
Unknown Facility
Newport Beach, California, 92663, United States
Unknown Facility
Rancho Mirage, California, 92270, United States
Unknown Facility
New Haven, Connecticut, 06510, United States
Unknown Facility
Newark, Delaware, 19702, United States
Unknown Facility
Washington D.C., District of Columbia, 20010, United States
Unknown Facility
Valparasio, Indiana, 46383, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
Lafayette, Louisiana, 70503, United States
Unknown Facility
Cumberland, Maryland, 21502, United States
Unknown Facility
Takoma Park, Maryland, 20912, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Burlington, Massachusetts, 01805, United States
Unknown Facility
Worcester, Massachusetts, 01655, United States
Unknown Facility
Ann Arbor, Michigan, 48109, United States
Unknown Facility
Grand Rapids, Michigan, 49506, United States
Unknown Facility
Ypsilanti, Michigan, 48197, United States
Unknown Facility
Kansas City, Missouri, 94520, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Flushing, New York, 11355, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
The Bronx, New York, 10463, United States
Unknown Facility
Winston-Salem, North Carolina, 27157, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Toledo, Ohio, 43615, United States
Unknown Facility
Portland, Oregon, 97225, United States
Unknown Facility
Salem, Oregon, 97301, United States
Unknown Facility
Langhorne, Pennsylvania, 08691, United States
Unknown Facility
Wynnewood, Pennsylvania, 19096, United States
Unknown Facility
Greenville, South Carolina, 29615, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Amarillo, Texas, 79106, United States
Unknown Facility
Mechanicsville, Virginia, 23116, United States
Unknown Facility
Virginia Beach, Virginia, 23454, United States
Unknown Facility
Spokane, Washington, 99204, United States
Related Publications (1)
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.
PMID: 26049048RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Studies Engineer
- Organization
- Biotronik, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2014
First Posted
March 26, 2014
Study Start
June 1, 2014
Primary Completion
March 1, 2015
Study Completion
June 1, 2015
Last Updated
February 29, 2016
Results First Posted
October 22, 2015
Record last verified: 2016-02