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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
January 8, 2016
January 12, 2016
November 20, 2017
January 2016
April 30, 2017   (Final data collection date for primary outcome measure)
  • 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
  • the MR scan-related System Complication Free Rate (CFR) [ Time Frame: 1 Month ]
  • Increase in RV pacing threshold [ Time Frame: 1 Month ]
  • Increase in LV pacing threshold [ Time Frame: 1 Month ]
  • Decrease in RV sensed amplitude [ Time Frame: 1 Month ]
  • Decrease in LV sensed amplitude [ Time Frame: 1 Month ]
Complete list of historical versions of study NCT02652481 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Expanding MRI Access for Patients With New and Existing ICDs and CRT-Ds ( ENABLE MRI)
Not Provided

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Magnetic Resonance Imaging
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

open label - 1 arm
prospective, non-randomized, confirmatory study
Intervention: Device: ImageReady MR Conditional Defibrillation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
500
December 2020
April 30, 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Germany,   Hong Kong,   Israel,   Italy,   Malaysia,   Palau,   Spain,   United Kingdom,   United States
 
 
NCT02652481
C1734
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
Plan to Share IPD: No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Study Director: Gregory Voss Boston Scientific Corporation
Boston Scientific Corporation
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP