ENABLE MRI (Magnetic Resonance Imaging) (ENABLE-MRI)

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

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.

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Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Device: ImageReady MR Conditional Defibrillation System

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
    • Academisch Ziekenhuis Middelheim
• Germany
  • Berlin, Germany
    • Deutsches Herzzentrum Berlin
  • Hannover, Germany
    • Medizinische Hochschule Hannover MHH
  • Magdeburg, Germany
    • Klinikum Magdeburg
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital
  • Hong Kong, Hong Kong
    • Prince Of Wales Hospital
• Israel
  • Haifa, Israel
    • Rambam Medical Center
  • Petah Tikva, Israel
    • Soroka MC
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center
  • Tel Hashomer, Israel
    • Hadassah Hebrew University Medical Center
• Italy
  • Campobasso, Italy
    • Fondazione di Ricerca e Cura 'Giovanni Paolo II'
  • Napoli, Italy
    • Azienda Ospedaliera Universitaria Federico II
  • Roma, Italy
    • Policlinico Casilino
  • Roma, Italy
    • Azienda Ospedaliera San Camillo-Forlanini
  • Roma, Italy
    • Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
  • Roma, Italy
    • Ospedale san giovanni calibita
  • Udine, Italy
    • Osp. S. Maria Della Misericordia
• Malaysia
  • Kuala Lumpur, Malaysia
    • Institut Jantung Negara
  • Kuala Lumpur, Malaysia
    • University of Malaya Medical Centre
• Spain
  • Barcelona, Spain
    • Hospital Clinic de Barcelona
• United Kingdom
  • Liverpool, United Kingdom
    • Heart and Chest Hospital
  • London, United Kingdom
    • Guys and St. Thomas NHS Foundation Trust
  • Newcastle, United Kingdom
    • Freeman Hospital
• United States
  • Alabama
    • Huntsville, Alabama, United States
      • Heart Center Research, LLC
  • Arkansas
    • Jonesboro, Arkansas, United States, 72653
      • Cardiology Associates of Northeast Arkansas
  • California
    • Pasadena, California, United States
      • Huntington Memorial Hospital
    • San Diego, California, United States
      • University of California - San Diego-N
    • Walnut Creek, California, United States
      • John Muir Medical Center
  • Florida
    • Bradenton, Florida, United States
      • Manatee Memorial Hospital
    • Lakeland, Florida, United States
      • Lakeland Regional Medical Center
    • Tampa, Florida, United States
      • University Community Hospital
  • Georgia
    • Atlanta, Georgia, United States
      • Emory University Hospital
  • Illinois
    • Springfield, Illinois, United States
      • St. John's Hospital
  • Indiana
    • Indianapolis, Indiana, United States
      • St. Vincent's Hospital
  • Iowa
    • Iowa City, Iowa, United States
      • University of Iowa Hospitals and Clinics
  • Michigan
    • Marquette, Michigan, United States
      • Marquette General Hospital
  • Minnesota
    • Saint Cloud, Minnesota, United States
      • CentraCare Heart and Vascular Center
    • Saint Paul, Minnesota, United States
      • HealthEast St. Joseph's Hospital
  • Mississippi
    • Tupelo, Mississippi, United States
      • North Mississippi Medical Center
  • Missouri
    • Springfield, Missouri, United States
      • Cox Health
  • New York
    • New York, New York, United States
      • Northwell Health
  • North Carolina
    • Chapel Hill, North Carolina, United States
      • University of North Carolina Hospital
  • Ohio
    • Columbus, Ohio, United States
      • OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
    • Toledo, Ohio, United States
      • The Toledo Hospital
  • Oregon
    • Portland, Oregon, United States
      • Providence St. Vincent Medical Center
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States
      • Bryn Mawr Medical Specialists
    • Philadelphia, Pennsylvania, United States
      • Thomas Jefferson University Hospital
  • South Dakota
    • Rapid City, South Dakota, United States
      • Rapid City Regional Hospital
  • Tennessee
    • Nashville, Tennessee, United States
      • St. Thomas Research Institute, LLC
  • Texas
    • Beaumont, Texas, United States
      • Southeast Texas Clinical Research Center
    • The Woodlands, Texas, United States
      • University of Texas Houston Health Science Center
    • Tyler, Texas, United States
      • Trinity Mother Frances Health System
  • Utah
    • Salt Lake City, Utah, United States
      • University of Utah Hospital and Clinics
  • Virginia
    • Norfolk, Virginia, United States
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States
      • Virginia Commonwealth University Health System
  • Washington
    • Everett, Washington, United States
      • Providence Regional Medical Center Everett
    • Vancouver, Washington, United States
      • PeaceHealth Southwest Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: ImageReady MR Conditional Defibrillation System Group; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Gregory Voss, Boston Scientific Corporation

Publications and helpful links

General Publications

• Rinaldi CA, Vitoff PJ, Nair DG, Bernstein R, Mountantonakis SE, Rapacciuolo A, Carter N, Tse HF, Green UB. Safety of magnetic resonance imaging scanning in patients with cardiac resynchronization therapy-defibrillators incorporating quadripolar left ventricular leads. Heart Rhythm. 2020 Dec;17(12):2064-2071. doi: 10.1016/j.hrthm.2020.08.020. Epub 2020 Sep 7.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): April 30, 2017
• Study Completion (Actual): May 4, 2018

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: C1734

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes