ENABLE MRI (Magnetic Resonance Imaging)

NCT02652481 | Completed Results FDA Device

• 1 other identifier: C1734
• Study Type: interventional
• Target: 500
• Locations: 9 countries
• Sites: 57

Brief Summary

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. .

Conditions

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

ImageReady MR Conditional Defibrillation System Group

OTHER

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

Interventions

ImageReady MR Conditional Defibrillation System DEVICE

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

ImageReady MR Conditional Defibrillation System Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Subject will receive or is implanted with an ICD or CRT-D pulse generator in the left or right pectoral region
• Subject is able and willing to undergo an MR scan without intravenous sedation (Phase I only)
• 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
• Subject is age 18 or above, or of legal age to give informed consent specific to state and national law

You may not qualify if:

• Subject implanted with an ICD or CRT-D pulse generator with battery at Explant status
• Subject has other active or abandoned implanted cardiac rhythm devices, components or accessories present such as pulse generators, leads, lead adaptors or extenders
• 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
• Subject needs or will need a medically necessary MR scan, before completing the 1-month post-MR follow-up visit (Phase I only)
• 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
• 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
• 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
• 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)
• Subjects with an implanted lead that is planned to be extracted during the study implant procedure
• Subjects currently requiring dialysis

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (57)

Heart Center Research, LLC

Huntsville, Alabama, United States

Location

Cardiology Associates of Northeast Arkansas

Jonesboro, Arkansas, 72653, United States

Location

Huntington Memorial Hospital

Pasadena, California, United States

Location

University of California - San Diego-N

San Diego, California, United States

Location

John Muir Medical Center

Walnut Creek, California, United States

Location

Manatee Memorial Hospital

Bradenton, Florida, United States

Location

Lakeland Regional Medical Center

Lakeland, Florida, United States

Location

University Community Hospital

Tampa, Florida, United States

Location

Emory University Hospital

Atlanta, Georgia, United States

Location

St. John's hospital

Springfield, Illinois, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Location

Marquette General Hospital

Marquette, Michigan, United States

Location

Centracare Heart and Vascular Center

Saint Cloud, Minnesota, United States

Location

HealthEast St. Joseph's Hospital

Saint Paul, Minnesota, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, United States

Location

Cox Health

Springfield, Missouri, United States

Location

Northwell Health

New York, New York, United States

Location

University of North Carolina Hospital

Chapel Hill, North Carolina, United States

Location

OhioHealth Research and Innovation Institute - Riverside Methodist Hospital

Columbus, Ohio, United States

Location

The Toledo Hospital

Toledo, Ohio, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, United States

Location

Bryn Mawr Medical Specialists

Bryn Mawr, Pennsylvania, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Location

St. Thomas Research Institute, LLC

Nashville, Tennessee, United States

Location

SouthEast Texas Clinical Research Center

Beaumont, Texas, United States

Location

University of Texas Houston Health Science Center

The Woodlands, Texas, United States

Location

Trinity Mother Frances Health System

Tyler, Texas, United States

Location

University of Utah Hospital and Clinics

Salt Lake City, Utah, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Location

Virginia Commonwealth University Health System

Richmond, Virginia, United States

Location

Providence Regional Medical Center Everett

Everett, Washington, United States

Location

PeaceHealth Southwest Medical

Vancouver, Washington, United States

Location

Academisch Ziekenhuis Middelheim

Antwerp, Belgium

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Medizinische Hochschule Hannover MHH

Hanover, Germany

Location

Klinikum Magdeburg

Magdeburg, Germany

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Rambam Medical Center

Haifa, Israel

Location

Soroka MC

Petah Tikva, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Hadassah Hebrew University Medical Center

Tel Litwinsky, Israel

Location

Fondazione di Ricerca e Cura 'Giovanni Paolo II'

Campobasso, Italy

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, Italy

Location

Azienda Ospedaliera San Camillo-Forlanini

Roma, Italy

Location

Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina

Roma, Italy

Location

Ospedale san giovanni calibita

Roma, Italy

Location

Policlinico Casilino

Roma, Italy

Location

Osp. S. Maria Della Misericordia

Udine, Italy

Location

Institut Jantung Negara

Kuala Lumpur, Malaysia

Location

University of Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Hospital Clinic de Barcelona

Barcelona, Spain

Location

Heart and Chest Hospital

Liverpool, United Kingdom

Location

Guys and St. Thomas NHS Foundation Trust

London, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32911050 DERIVED

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Boston Scientific

anneleen.viville@bsci.com

+32479983495

Study Officials

• Gregory Voss

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2016
• First Posted: January 12, 2016
• Study Start: January 1, 2016
• Primary Completion: April 30, 2017
• Study Completion: May 4, 2018
• Last Updated: January 25, 2021
• Results First Posted: July 16, 2019

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); US (34); IT (7); GB (3); MY (2); HK (2); IL (4); ES (1); DE (3)