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Expanding MRI Access for Patients With New and Existing ICDs and CRT-Ds ( ENABLE MRI) (ENABLE MRI)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02652481
First Posted: January 12, 2016
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  Purpose

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.


Condition Intervention
Magnetic Resonance Imaging Device: ImageReady MR Conditional Defibrillation System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • MR scan-related System Complication Free Rate (CFR) [ Time Frame: 1 Month ]
    MR scan-related Complication-free rate between the MR Scan and the MRI + 1 Month Visit

  • Increase in RV pacing threshold [ Time Frame: 1 Month ]
    Increase in RV pacing threshold from the pre-MR scan to the 1 Month post-MR scan

  • Increase in LV pacing threshold [ Time Frame: 1 Month ]
    Increase in LV pacing threshold from the pre-MR scan to the 1 Monthpost-MR scan

  • Decrease in RV sensed amplitude [ Time Frame: 1 Month ]
    Decrease in RV sensed amplitude from the pre-MR scan to the 1 Month post-MR scan

  • Decrease in LV sensed amplitude [ Time Frame: 1 Month ]
    Decrease in LV sensed amplitude from the pre-MR scan to the 1 Month post-MR scan


Estimated Enrollment: 500
Study Start Date: January 2016
Estimated Study Completion Date: December 2020
Primary Completion Date: April 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
open label - 1 arm
prospective, non-randomized, confirmatory study
Device: ImageReady 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 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


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 block
    • Documentation of progressive AV nodal block over time
    • 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.
  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, RV or LV 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 sedation, general anesthesia)
  3. Planned cardiac revascularization procedure
  4. Right Ventricular Lead R wave is less than 5 mV
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652481


  Show 57 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Gregory Voss Boston Scientific Corporation
  More Information

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02652481     History of Changes
Other Study ID Numbers: C1734
First Submitted: January 8, 2016
First Posted: January 12, 2016
Last Update Posted: November 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No