Magnetic Resonance Imaging
Conditions
Brief summary
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. .
Interventions
DEVICEImageReady MR Conditional Defibrillation System
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
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Phase I: Subject is indicated per guidelines and will receive a CRT-D or ICD system OR Subject is implanted with a functional and stable CRT-D or ICD system Phase II: Subject is implanted with a functional and stable CRT-D or ICD system 2. Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region 3. Subject is able and willing to undergo an MR scan without intravenous sedation (Phase I only) 4. Subject is willing and capable of providing informed consent and participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol 5. Subject is age 18 or above, or of legal age to give informed consent specific to state and national law Key
Exclusion criteria
1. Subject implanted with an ICD or CRT-D pulse generator with battery at Explant status 2. Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders 3. Presence of metallic objects that represent a contraindication to MR imaging at the discretion of the Radiologist and impacting the ability to conduct the study protocol 4. Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit (Phase I only) 5. Subject with: * A history of syncope related to brady-arrhythmia * A history of syncope of unknown etiology * Sinus pauses (Pause \> 2 s) * Permanent or intermittent complete AV (Atrioventricular ) block * Documentation of progressive AV nodal block over time * Trifascicular block (alternating bundle branch block or PR \> 200 ms (interval between P wave and R-wave) with LBBB ( Left bundle branch block) or other bifascicular block) Note: It is required to run a 12 lead ECG (Electrocardiography) and a 10s rhythm strip to document this exclusion criterion. During ECG acquisition, subjects must be in either their own intrinsic rhythm or, in subjects with an existing device implant, the device must be programmed to VVI (ventricular demand pacing) 40 ppm. 6. Subject is not clinically capable of tolerating the absence of pacing or Resynchronization therapy support in a supine position for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion 7. Subject is not clinically capable of tolerating the absence of Tachycardia therapy support for the duration that the pulse generator is in MRI Protection Mode, per Physician discretion 8. Subjects with a planned RA( right atrium), RV ( right ventricle) or LV (left ventricle) lead revision or extraction within 30 days of enrollment (Phase I only) 9. Subjects with an implanted lead that is planned to be extracted during the study implant procedure 10. Subjects currently requiring dialysis 11. Subject has a mechanical heart valve 12. Subject has a known or suspected sensitivity to dexamethasone acetate (DXA) 13. Subject is currently on the active heart transplant list 14. Subject has documented life expectancy of less than 12 months 15. Subject is enrolled in a concurrent study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific 16. Women of childbearing potential who are or might be pregnant, and will receive an ICD or CRT-D pulse generator VF Induction Sub-study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications | The time between the MR Scan and MRI + 1 Month | MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit |
| Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV | The time between the MR Scan and MRI + 1 Month | 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. |
| Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms. | The time between the MR Scan and MRI + 1 Month | 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. |
| Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude | The time between the MR Scan and MRI + 1 Month | 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. |
| Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude | The time between the MR Scan and MRI + 1 Month | 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. |
Countries
Belgium, Germany, Hong Kong, Israel, Italy, Malaysia, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ImageReady™ MR Conditional Defibrillation System This is a prospective, non-randomized, confirmatory study. Some defibrillator systems are not able to be used with MRI scanners because the material they are made out. Boston Scientific has a defibrillation system with a new feature that blocks interference from an MRI scanner when the defibrillator system is set to the MRI protection mode. This new MRI scan feature was considered investigational , meaning was investigated because it was not approved by the US Food and Drug Administration (FDA) for patient use. This new defibrillation system is called the ImageReady Defibrillation System. Together, the defibrillator and the lead(s) are called the ImageReady System. The ImageReady system is considered investigational in the US because not all the component parts are approved by the FDA. Patients who have a ImageReady defibrillator will undergo an MRI and data will be collected. Periodic checks were planned to check the defibrillator system. | 498 |
| Total | 498 |
Baseline characteristics
| Characteristic | ImageReady™ MR Conditional Defibrillation System |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 12 |
| BMI | 29.0 kg/m^2 STANDARD_DEVIATION 6.1 |
| Race/Ethnicity, Customized Race American Indian | 3 Participants |
| Race/Ethnicity, Customized Race Asian | 42 Participants |
| Race/Ethnicity, Customized Race Black or African heritage | 45 Participants |
| Race/Ethnicity, Customized Race Caucasian | 381 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 6 Participants |
| Race/Ethnicity, Customized Race Other | 5 Participants |
| Race/Ethnicity, Customized Race Unknown | 16 Participants |
| Region of Enrollment Austria | 12 Participants |
| Region of Enrollment Belgium | 3 Participants |
| Region of Enrollment Germany | 19 Participants |
| Region of Enrollment Hong Kong | 19 Participants |
| Region of Enrollment Israel | 6 Participants |
| Region of Enrollment Italy | 87 Participants |
| Region of Enrollment Malaysia | 20 Participants |
| Region of Enrollment Spain | 10 Participants |
| Region of Enrollment United Kingdom | 20 Participants |
| Region of Enrollment United States | 302 Participants |
| Sex: Female, Male Female | 136 Participants |
| Sex: Female, Male Male | 362 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 18 / 495 |
| other Total, other adverse events | 122 / 495 |
| serious Total, serious adverse events | 139 / 495 |
Outcome results
Primary
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
Population: All implanted subjects that completed any portion of the study required MR scan and did not have a Medically Necessary Scan (MNS) performed prior to the MRI+1 Month Visit were included in the Primary Safety Endpoint analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady MR Conditional Defibrillation System Group | Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications | 100 percentage of participants |
Primary
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
Population: did not include subjects with a MNS between implant and the MRI + 1 Month Visit;failed to meet labeled MRI Conditions of Use, had lead-related complication;had an incomplete scan or no scan; missing lead measurements; missed a visits, subject died or withdrew consent; Average LV sensed amplitude \<5mV (3 patients)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady MR Conditional Defibrillation System Group | Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude | 98.31 percentage of participants with succes |
Primary
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
Population: Did not include subjects that had a MNS between implant and the MRI+1Month Visit; Failed to meet Conditions of Use; Experienced lead-related complication; Had an incomplete scan or no scan, died or withdrew consent, missed a visit, missed lead measurements; had an average pre-scan RV sensed amplitude measurement \< 5.0 mV.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady MR Conditional Defibrillation System Group | Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude | 99.32 percentage of participants with succes |
Primary
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
Population: did not include subjects with a MNS between implant and the MRI + 1 Month Visit;failed to meet labeled MRI Conditions of Use, had lead-related complication;had an incomplete scan or no scan; missing lead measurements; missed a visits, subject died or withdrew consent
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady MR Conditional Defibrillation System Group | Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms. | 100 percentage of participants with succes |
Primary
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
Population: Did not include subjects that had a MNS between implant and the MRI+1Month Visit; Failed to meet Conditions of Use; Experienced lead-related complication; Had an incomplete scan or no scan, died or withdrew consent, missed a visit, missed lead measurements
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ImageReady MR Conditional Defibrillation System Group | Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV | 99.32 percentage of participants with success |