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The objective of the ProMRI Study is to demonstrate the clinical safety of the ProMRI ICD System when used under specific MRI conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICD System Therapy | Patients with a ProMRI ICD System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with a ProMRI ICD System | Device | Tachycardia Fast Heart Beat |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
The following initial inclusion criteria must be met for a subject to be enrolled and considered for the MRI-procedure:
At the pre-MRI procedure, the following procedure-related criteria must be met for the subject to undergo the MRI scan:
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The patients selected for participation should be from the investigators' general patient population according to the inclusion and exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35294 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26049048 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Magnetic Resonance Imaging (MRI) scan |
| Other |
MRI scan of heart/chest or thoracic spine |
|
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Scottsdale | Arizona | 85251 | United States |
| Concord | California | 94520 | United States |
| Newport Beach | California | 92663 | United States |
| Rancho Mirage | California | 92270 | United States |
| New Haven | Connecticut | 06510 | United States |
| Newark | Delaware | 19702 | United States |
| Washington D.C. | District of Columbia | 20010 | United States |
| Valparasio | Indiana | 46383 | United States |
| Iowa City | Iowa | 52242 | United States |
| Lafayette | Louisiana | 70503 | United States |
| Cumberland | Maryland | 21502 | United States |
| Takoma Park | Maryland | 20912 | United States |
| Boston | Massachusetts | 02114 | United States |
| Burlington | Massachusetts | 01805 | United States |
| Worcester | Massachusetts | 01655 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Grand Rapids | Michigan | 49506 | United States |
| Ypsilanti | Michigan | 48197 | United States |
| Kansas City | Missouri | 94520 | United States |
| St Louis | Missouri | 63110 | United States |
| Flushing | New York | 11355 | United States |
| New York | New York | 10016 | United States |
| New York | New York | 10021 | United States |
| The Bronx | New York | 10463 | United States |
| Winston-Salem | North Carolina | 27157 | United States |
| Columbus | Ohio | 43210 | United States |
| Toledo | Ohio | 43615 | United States |
| Portland | Oregon | 97225 | United States |
| Salem | Oregon | 97301 | United States |
| Langhorne | Pennsylvania | 08691 | United States |
| Wynnewood | Pennsylvania | 19096 | United States |
| Greenville | South Carolina | 29615 | United States |
| Nashville | Tennessee | 37232 | United States |
| Amarillo | Texas | 79106 | United States |
| Mechanicsville | Virginia | 23116 | United States |
| Virginia Beach | Virginia | 23454 | United States |
| Spokane | Washington | 99204 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MRI and ICD System Related Serious Adverse Device Effect (SADE) Free Rate | Posted | Number | 95% Confidence Interval | percentage of participants | 1 Month Post-MRI |
|
|
| |||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Between Pre-MRI and 1 Month Post-MRI |
|
| |||||||||||||||||||||||||||
| Primary | 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. | All participants who had measurable R-waves at both pre-MRI and and 1 Month Post-MRI. | Posted | Number | 95% Confidence Interval | percentage of participants | Between Pre-MRI and 1 Month Post-MRI |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 23 | 154 | 24 | 154 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina | Cardiac disorders | Systematic Assessment |
| ||
| Arrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Infection | General disorders | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Sinus Thrombosis | General disorders | Systematic Assessment | Incidental finding from review of study MRI scan. |
| |
| Medication Related | General disorders | Systematic Assessment |
| ||
| Musculoskeletal Pain or Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Peripheral Vascular Disease | Vascular disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Obstructive Sleep Apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Stroke | Nervous system disorders | Systematic Assessment |
| ||
| Syncope/Pre-Syncope | Cardiac disorders | Systematic Assessment |
| ||
| Worsening Chronic Heart Failure | Cardiac disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MRI Incidental Finding | General disorders | Systematic Assessment |
|
Principal Investigators agree to submit copies of any manuscript proposed for publication to Sponsor for review at least 30 days in advance of submission for publication or presentation. Sponsor may extend such review period for another 90 days to file patent applications or take other steps to protect its intellectual property interests, or to remove from the paper or presentation any language that is detrimental to Sponsor's intellectual property interests.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Studies Engineer | Biotronik, Inc. | 503-451-8049 | justin.michalski@biotronik.com |
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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