The objective of this study is to collect data to confirm the safety and effectiveness of the Image Ready™ MR (Magnetic Resonance) Conditional Defibrillation System when used in the 1.5T (Tesla) MRI environment under the labeled Conditions of Use (Phase I). Additionally, the study will assess medically necessary MR scans according to the labeled Conditions of Use to provide real-world scanning data (Phase I and Phase II).The study also aims to demonstrate the continued ability of the ImageReady MR Conditional Defibrillation System to sense and detect ventricular fibrillation (VF) post MRI scan by collecting and analyzing data from spontaneous VF episodes, "for-cause" VF inductions, and from an optional VF induction Sub-study. .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
500
ImageReady MR Conditional Defibrillation System Components: Device Name Device Model Number Pulse Generators Phase I and II Phase II Only \* CRT-D (IS1/DF4/IS4) VR ICD (DF4) DR ( dual chamber) ICD (IS1/DF4) ORIGEN™ MINI ICD ORIGEN EL ICD ORIGEN X4 CRT INOGEN™ MINI ICD INOGEN EL ICD INOGEN X4 CRT DYNAGEN™ MINI ICD DYNAGEN EL ICD DYNAGEN X4 CRT-D AUTOGEN ™ MINI ICD\* AUTOGEN EL ICD\* AUTOGEN X4 CRT-D\* Right Atrial Leads and Accessories FINELINE™ II Sterox FINELINE II Sterox EZ Suture Sleeves for FINELINE II Leads INGEVITY™ MRI\* Suture Sleeve for INGEVITY MRI\* IS-1 Lead Port Plug 7145 Right Ventricular Leads and Accessories RELIANCE 4-FRONT™ (DF4)\* Suture Sleeve for RELIANCE 4-FRONT leads\*; ENDOTAK RELIANCE™ (DF4) Left Ventricular Leads and Accessories ACUITY™ X4 (IS4) Suture Sleeve for ACUITY X4 leads \* May only be used internationally outside the US
Heart Center Research, LLC
Huntsville, Alabama, United States
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, United States
Huntington Memorial Hospital
Pasadena, California, United States
University of California - San Diego-N
San Diego, California, United States
John Muir Medical Center
Walnut Creek, California, United States
Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications
MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit
Time frame: The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV
Increases in RV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in average pacing thresholds ≤ 0.5V (at 0.5 ms) from pre-MR Scan to MRI Visit + 1 Month follow-up were considered a success.
Time frame: The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms.
Increases in average LV pacing threshold (at 0.5 ms) pre- MR scan and 1 Month post-MR scan were calculated for subjects. Subjects that had an increase in pacing thresholds measurements ≤ 1.0V (at 0.5 ms) from pre-MR Scan at MRI Visit to MRI + 1 Month Visit were considered a success.
Time frame: The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude
Decreases in RV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remains ≥ 5.0 mV and above 50% of the pre-MR scan value. Subjects who had an average pre-scan RV sensed amplitude measurement \< 5.0 mV were excluded from this analysis.
Time frame: The time between the MR Scan and MRI + 1 Month
Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude
Decreases in average LV sensed amplitude pre-MR scan and 1 Month post-MR scan were calculated for subjects. Subjects were considered a success if the average sensed amplitude at the MRI + 1 Month Visit remained ≥ 5.0 mV and above 50% of the average pre-MR scan value. Subjects who had an average pre-scan LV sensed amplitude measurement \< 5.0 mV were excluded from this analysis.
Time frame: The time between the MR Scan and MRI + 1 Month
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Manatee Memorial Hospital
Bradenton, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
University Community Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
St. John's hospital
Springfield, Illinois, United States
...and 47 more locations