ENABLE MRI (Magnetic Resonance Imaging)

Study Overview
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Brief Summary
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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. .

Official Title
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Expanding MRI (Magnetic Resonance Imaging) Access for Patients With New and Existing ICDs (Implantable Cardioverter Defibrillator) and CRT-Ds (Cardiac Resynchronization Therapy Defibrillator)

Conditions
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Magnetic Resonance Imaging

Intervention / Treatment
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* Device: ImageReady MR Conditional Defibrillation System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region Subject is able and willing to undergo an MR scan without intravenous sedation (Phase I only) 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 Subject is age 18 or above, or of legal age to give informed consent specific to state and national law Key Exclusion Criteria: Subject implanted with an ICD or CRT-D pulse generator with battery at Explant status Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders 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 Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit (Phase I only) 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. 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 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 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) Subjects with an implanted lead that is planned to be extracted during the study implant procedure Subjects currently requiring dialysis Subject has a mechanical heart valve Subject has a known or suspected sensitivity to dexamethasone acetate (DXA) Subject is currently on the active heart transplant list Subject has documented life expectancy of less than 12 months 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 Women of childbearing potential who are or might be pregnant, and will receive an ICD or CRT-D pulse generator VF Induction Sub-study Exclusion Criteria: In addition to meeting all of the inclusion criteria and none of the exclusion criteria of the ENABLE MRI study, subjects enrolled in the VF Induction Sub-study must also not meet any of the following VF Induction Sub-study exclusion criteria: Unstable heart failure requiring hospitalization in the last 30 calendar days Unable to tolerate sedation (e.g. IV (intravenous sedation )sedation, general anesthesia) Planned cardiac revascularization procedure Right Ventricular Lead R wave is less than 5 mV(milliVolt)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ImageReady MR Conditional Defibrillation System Group<br>Prospective, non-randomized, confirmatory study.Subjects will initially be enrolled into Phase I to undergo a non-diagnostic study required MR Scan. Once Phase I is complete, subjects will be enrolled into Phase II where there is no requirement to undergo a non-diagnostic study required MR scan Up to 37 subjects will be used for an interim analysis. Of these subjects, the first 20 who undergo the study required MRI scan and complete the MRI + 1 Month Visit will be used for this analysis. The second cohort will consist of subjects who will receive the non-diagnostic study required MR scan until 137 CRT-D and 28 VR ( single chamber) ICD subjects undergo the study required MR scan (complete or incomplete). De novo implants and existing implants may be enrolled in Phase I There will be a non-diagnostic study required MR scan (during the MRI visit) There will be a study required MRI visit and MRI + 1 month visit | Device: ImageReady MR Conditional Defibrillation System<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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. | 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. | The time between the MR Scan and MRI + 1 Month |