Study Results
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View full resultsBasic Information
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COMPLETED
NA
500 participants
INTERVENTIONAL
2016-01-31
2018-05-04
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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)
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Voss
Role: STUDY_DIRECTOR
Boston Scientific Corporation
Locations
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Heart Center Research, LLC
Huntsville, Alabama, United States
Cardiology Associates of Northeast Arkansas
Jonesboro, Arkansas, United States
Huntington Memorial Hospital
Pasadena, California, United States
University of California - San Diego-N
San Diego, California, United States
John Muir Medical Center
Walnut Creek, California, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
University Community Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
St. John's hospital
Springfield, Illinois, United States
St. Vincent's Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Marquette General Hospital
Marquette, Michigan, United States
Centracare Heart and Vascular Center
Saint Cloud, Minnesota, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
Cox Health
Springfield, Missouri, United States
Northwell Health
New York, New York, United States
University of North Carolina Hospital
Chapel Hill, North Carolina, United States
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital
Columbus, Ohio, United States
The Toledo Hospital
Toledo, Ohio, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Bryn Mawr Medical Specialists
Bryn Mawr, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
St. Thomas Research Institute, LLC
Nashville, Tennessee, United States
SouthEast Texas Clinical Research Center
Beaumont, Texas, United States
University of Texas Houston Health Science Center
The Woodlands, Texas, United States
Trinity Mother Frances Health System
Tyler, Texas, United States
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
Providence Regional Medical Center Everett
Everett, Washington, United States
PeaceHealth Southwest Medical
Vancouver, Washington, United States
Academisch Ziekenhuis Middelheim
Antwerp, , Belgium
Deutsches Herzzentrum Berlin
Berlin, , Germany
Medizinische Hochschule Hannover MHH
Hanover, , Germany
Klinikum Magdeburg
Magdeburg, , Germany
Prince of Wales Hospital
Hong Kong, , Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Rambam Medical Center
Haifa, , Israel
Soroka MC
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Hadassah Hebrew University Medical Center
Tel Litwinsky, , Israel
Fondazione di Ricerca e Cura 'Giovanni Paolo II'
Campobasso, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma, , Italy
Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina
Roma, , Italy
Ospedale san giovanni calibita
Roma, , Italy
Policlinico Casilino
Roma, , Italy
Osp. S. Maria Della Misericordia
Udine, , Italy
Institut Jantung Negara
Kuala Lumpur, , Malaysia
University of Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Clinic de Barcelona
Barcelona, , Spain
Heart and Chest Hospital
Liverpool, , United Kingdom
Guys and St. Thomas NHS Foundation Trust
London, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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C1734
Identifier Type: -
Identifier Source: org_study_id
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