ENABLE MRI (Magnetic Resonance Imaging)

Not Applicable

Completed

Conditions: Magnetic Resonance Imaging

Interventions: Device: ImageReady MR Conditional Defibrillation System

Registration Number: NCT02652481

Lead Sponsor: Boston Scientific Corporation

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.

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Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 500

Inclusion Criteria

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

Key

Exclusion Criteria

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
- 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.
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
Subject has a mechanical heart valve
Subject has a known or suspected sensitivity to dexamethasone acetate (DXA)
Subject is currently on the active heart transplant list
Subject has documented life expectancy of less than 12 months
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
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:

Unstable heart failure requiring hospitalization in the last 30 calendar days
Unable to tolerate sedation (e.g. IV (intravenous sedation )sedation, general anesthesia)
Planned cardiac revascularization procedure
Right Ventricular Lead R wave is less than 5 mV(milliVolt)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ImageReady MR Conditional Defibrillation System Group	ImageReady MR Conditional Defibrillation System	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

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications	The time between the MR Scan and MRI + 1 Month	MR scan-related CFR (Complication-free rate) between the MR Scan and the MRI + 1 (Magnetic Resonance Imaging) Month Visit
Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms.	The time between the MR Scan and MRI + 1 Month	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.
Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude	The time between the MR Scan and MRI + 1 Month	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.
Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV	The time between the MR Scan and MRI + 1 Month	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.
Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude	The time between the MR Scan and MRI + 1 Month	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (57): Cardiology Associates of Northeast Arkansas
🇺🇸
Jonesboro, Arkansas, United States
HealthEast St. Joseph's Hospital
🇺🇸
Saint Paul, Minnesota, United States
Manatee Memorial Hospital
🇺🇸
Bradenton, Florida, United States
Huntington Memorial Hospital
🇺🇸
Pasadena, California, United States
University Community Hospital
🇺🇸
Tampa, Florida, United States
Tel Aviv Sourasky Medical Center
🇮🇱
Tel Aviv, Israel
Marquette General Hospital
🇺🇸
Marquette, Michigan, United States
Providence St. Vincent Medical Center
🇺🇸
Portland, Oregon, United States
Lakeland Regional Medical Center
🇺🇸
Lakeland, Florida, United States
Soroka MC
🇮🇱
Petah Tikva, Israel
Hadassah Hebrew University Medical Center
🇮🇱
Tel Hashomer, Israel
Azienda Ospedaliera Universitaria Federico II
🇮🇹
Napoli, Italy
Ospedale san giovanni calibita
🇮🇹
Roma, Italy
Osp. S. Maria Della Misericordia
🇮🇹
Udine, Italy
Institut Jantung Negara
🇲🇾
Kuala Lumpur, Malaysia
Centracare Heart and Vascular Center
🇺🇸
Saint Cloud, Minnesota, United States
Heart Center Research, LLC
🇺🇸
Huntsville, Alabama, United States
John Muir Medical Center
🇺🇸
Walnut Creek, California, United States
University of California - San Diego-N
🇺🇸
San Diego, California, United States
St. John's hospital
🇺🇸
Springfield, Illinois, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
St. Vincent's Hospital
🇺🇸
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
Cox Health
🇺🇸
Springfield, Missouri, United States
North Mississippi Medical Center
🇺🇸
Tupelo, Mississippi, United States
University of North Carolina Hospital
🇺🇸
Chapel Hill, North Carolina, United States
Northwell Health
🇺🇸
New York, New York, United States
Bryn Mawr Medical Specialists
🇺🇸
Bryn Mawr, Pennsylvania, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
🇺🇸
Columbus, Ohio, United States
The Toledo Hospital
🇺🇸
Toledo, Ohio, United States
Thomas Jefferson University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
SouthEast Texas Clinical Research Center
🇺🇸
Beaumont, Texas, United States
Rapid City Regional Hospital
🇺🇸
Rapid City, South Dakota, United States
St. Thomas Research Institute, LLC
🇺🇸
Nashville, Tennessee, United States
Trinity Mother Frances Health System
🇺🇸
Tyler, Texas, United States
University of Texas Houston Health Science Center
🇺🇸
The Woodlands, Texas, United States
PeaceHealth Southwest Medical
🇺🇸
Vancouver, Washington, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Virginia Commonwealth University Health System
🇺🇸
Richmond, Virginia, United States
University of Utah Hospital and Clinics
🇺🇸
Salt Lake City, Utah, United States
Providence Regional Medical Center Everett
🇺🇸
Everett, Washington, United States
Academisch Ziekenhuis Middelheim
🇧🇪
Antwerp, Belgium
Medizinische Hochschule Hannover MHH
🇩🇪
Hannover, Germany
Deutsches Herzzentrum Berlin
🇩🇪
Berlin, Germany
Klinikum Magdeburg
🇩🇪
Magdeburg, Germany
Queen Mary Hospital
🇭🇰
Hong Kong, Hong Kong
Prince of Wales Hospital
🇭🇰
Hong Kong, Hong Kong
Rambam Medical Center
🇮🇱
Haifa, Israel
Fondazione di Ricerca e Cura 'Giovanni Paolo II'
🇮🇹
Campobasso, Italy
Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
🇮🇹
Roma, Italy
Azienda Ospedaliera San Camillo-Forlanini
🇮🇹
Roma, Italy
Policlinico Casilino
🇮🇹
Roma, Italy
University of Malaya Medical Centre
🇲🇾
Kuala Lumpur, Malaysia
Hospital Clinic de Barcelona
🇪🇸
Barcelona, Spain
Guys and St. Thomas NHS Foundation Trust
🇬🇧
London, United Kingdom
Heart and Chest Hospital
🇬🇧
Liverpool, United Kingdom
Freeman Hospital
🇬🇧
Newcastle, United Kingdom