Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:

Description

Summary

The objective of this study is to collect data to confirm the safety and effectiveness of the ImageReady™ MR Conditional Defibrillation System when used in the 1.5T 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.

Keywords

Magnetic Resonance Imaging ImageReady MR Conditional Defibrillation System

Eligibility

For people ages 18 years and up

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

  1. Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region
  2. Subject is able and willing to undergo an MR scan without intravenous sedation (Phase I only)
  3. 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
  4. 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:
  6. A history of syncope related to brady-arrhythmia
  7. A history of syncope of unknown etiology
  8. Sinus pauses (Pause > 2 s)
  9. Permanent or intermittent complete AV block
  10. Documentation of progressive AV nodal block over time
  11. Trifascicular block (alternating bundle branch block or PR > 200 ms with LBBB or other bifascicular block) Note: It is required to run a 12 lead ECG 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 40 ppm.
  12. 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
  13. 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
  14. Subjects with a planned RA, RV or LV lead revision or extraction within 30 days of enrollment (Phase I only)
  15. Subjects with an implanted lead that is planned to be extracted during the study implant procedure
  16. . Subjects currently requiring dialysis
  17. . Subject has a mechanical heart valve
  18. . Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
  19. . Subject is currently on the active heart transplant list
  20. . Subject has documented life expectancy of less than 12 months
  21. . 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
  22. . 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 sedation, general anesthesia)
  3. Planned cardiac revascularization procedure
  4. Right Ventricular Lead R wave is less than 5 mV

Locations

  • University of California - San Diego-N
    San Diego California United States
  • Huntington Memorial Hospital
    Pasadena California United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT02652481
Study Type
Interventional
Last Updated
November 16, 2017