ENABLE MRI (Magnetic Resonance Imaging)

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2021
• Main ID: NCT02652481
• Date of registration: 08/01/2016
• Prospective Registration: No
• Primary sponsor: Boston Scientific Corporation
• Public title: ENABLE MRI (Magnetic Resonance Imaging) ENABLE-MRI
• Scientific title: Expanding MRI (Magnetic Resonance Imaging) Access for Patients With New and Existing ICDs (Implantable Cardioverter Defibrillator) and CRT-Ds (Cardiac Resynchronization Therapy Defibrillator)
• Date of first enrolment: January 2016
• Target sample size: 500
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02652481
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium, Germany, Hong Kong, Israel, Italy, Malaysia, Palau, Spain, United Kingdom, United States

Contacts

• Name: Gregory Voss
• Affiliation: Boston Scientific Corporation

Key inclusion & exclusion 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 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:

1. Unstable heart failure requiring hospitalization in the last 30 calendar days

2. Unable to tolerate sedation (e.g. IV (intravenous sedation )sedation, general
anesthesia)

3. Planned cardiac revascularization procedure

4. Right Ventricular Lead R wave is less than 5 mV(milliVolt)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Magnetic Resonance Imaging

Intervention(s)

Device: ImageReady MR Conditional Defibrillation System

Primary Outcome(s)

Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold = 1.0V (Volt) at 0.5 ms. [Time Frame: The time between the MR Scan and MRI + 1 Month]

Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude [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 [Time Frame: The time between the MR Scan and MRI + 1 Month]

Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications [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 [Time Frame: The time between the MR Scan and MRI + 1 Month]

Secondary ID(s)

C1734

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/07/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02652481