Clinical trial NCT02652481: ENABLE MRI (Magnetic Resonance Imaging)
Official title: Expanding MRI (Magnetic Resonance Imaging) Access for Patients With New and Existing ICDs (Implantable Cardioverter Defibrillator) and CRT-Ds (Cardiac Resynchronization Therapy Defibrillator)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Resonance Imaging
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-01-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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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Eligibility 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 (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)

Primary outcomes:
measure: Percentage of Participants Free From MR (Magnetic Resonance) Scan-related Complications
timeFrame: The time between the MR Scan and MRI + 1 Month
measure: Percentage of Participants That Had an Increase in Average Pacing Thresholds ≤ 0.5V (Volt) (at 0.5 ms) in the RV
timeFrame: The time between the MR Scan and MRI + 1 Month
measure: Percentage of Participants That Had an Increase in Average LV ( Left Ventricle) Pacing Threshold ≤ 1.0V (Volt) at 0.5 ms.
timeFrame: The time between the MR Scan and MRI + 1 Month
measure: Percentage of Participants That Had a Decrease in RV ( Right Ventricle) Sensed Amplitude
timeFrame: The time between the MR Scan and MRI + 1 Month
measure: Percentage of Participants That Decrease in LV ( Left Ventricle) Sensed Amplitude
timeFrame: The time between the MR Scan and MRI + 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Jonesboro
country: United States
facility: Cardiology Associates of Northeast Arkansas
state: Arkansas
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
city: San Diego
country: United States
facility: University of California - San Diego-N
state: California
city: Walnut Creek
country: United States
facility: John Muir Medical Center
state: California
city: Bradenton
country: United States
facility: Manatee Memorial Hospital
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Medical Center
state: Florida
city: Tampa
country: United States
facility: University Community Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Springfield
country: United States
facility: St. John's hospital
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent's Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Marquette
country: United States
facility: Marquette General Hospital
state: Michigan
city: Saint Cloud
country: United States
facility: Centracare Heart and Vascular Center
state: Minnesota
city: Saint Paul
country: United States
facility: HealthEast St. Joseph's Hospital
state: Minnesota
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: New York
country: United States
facility: Northwell Health
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospital
state: North Carolina
city: Columbus
country: United States
facility: OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Bryn Mawr
country: United States
facility: Bryn Mawr Medical Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Rapid City
country: United States
facility: Rapid City Regional Hospital
state: South Dakota
city: Nashville
country: United States
facility: St. Thomas Research Institute, LLC
state: Tennessee
city: Beaumont
country: United States
facility: SouthEast Texas Clinical Research Center
state: Texas
city: The Woodlands
country: United States
facility: University of Texas Houston Health Science Center
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances Health System
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinics
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Vancouver
country: United States
facility: PeaceHealth Southwest Medical
state: Washington
city: Antwerp
country: Belgium
facility: Academisch Ziekenhuis Middelheim
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover MHH
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petah Tikva
country: Israel
facility: Soroka MC
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel Hashomer
country: Israel
facility: Hadassah Hebrew University Medical Center
city: Campobasso
country: Italy
facility: Fondazione di Ricerca e Cura 'Giovanni Paolo II'
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo-Forlanini
city: Roma
country: Italy
facility: Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
city: Roma
country: Italy
facility: Ospedale san giovanni calibita
city: Roma
country: Italy
facility: Policlinico Casilino
city: Udine
country: Italy
facility: Osp. S. Maria Della Misericordia
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya Medical Centre
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Liverpool
country: United Kingdom
facility: Heart and Chest Hospital
city: London
country: United Kingdom
facility: Guys and St. Thomas NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
Study officials:
affiliation: Boston Scientific Corporation
name: Gregory Voss
role: STUDY_DIRECTOR
References:
citation: 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.