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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02652481
Other study ID # C1734
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2016
Est. completion date May 4, 2018

Study information

Verified date January 2021
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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. .


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date May 4, 2018
Est. primary completion date April 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium Academisch Ziekenhuis Middelheim Antwerp
Germany Deutsches Herzzentrum Berlin Berlin
Germany Medizinische Hochschule Hannover MHH Hannover
Germany Klinikum Magdeburg Magdeburg
Hong Kong Prince of Wales Hospital Hong Kong
Hong Kong Queen Mary Hospital Hong Kong
Israel Rambam Medical Center Haifa
Israel Soroka MC Petah Tikva
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Israel Hadassah Hebrew University Medical Center Tel Hashomer
Italy 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
Malaysia Institut Jantung Negara Kuala Lumpur
Malaysia University of Malaya Medical Centre Kuala Lumpur
Spain Hospital Clinic de Barcelona Barcelona
United Kingdom Heart and Chest Hospital Liverpool
United Kingdom Guys and St. Thomas NHS Foundation Trust London
United Kingdom Freeman Hospital Newcastle
United States Emory University Hospital Atlanta Georgia
United States SouthEast Texas Clinical Research Center Beaumont Texas
United States Manatee Memorial Hospital Bradenton Florida
United States Bryn Mawr Medical Specialists Bryn Mawr Pennsylvania
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 Providence Regional Medical Center Everett Everett Washington
United States Heart Center Research, LLC Huntsville Alabama
United States St. Vincent's Hospital Indianapolis Indiana
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Cardiology Associates of Northeast Arkansas Jonesboro Arkansas
United States Lakeland Regional Medical Center Lakeland Florida
United States Marquette General Hospital Marquette Michigan
United States St. Thomas Research Institute, LLC Nashville Tennessee
United States Northwell Health New York New York
United States Sentara Norfolk General Hospital Norfolk Virginia
United States Huntington Memorial Hospital Pasadena California
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Providence St. Vincent Medical Center Portland Oregon
United States Rapid City Regional Hospital Rapid City South Dakota
United States Virginia Commonwealth University Health System Richmond Virginia
United States Centracare Heart and Vascular Center Saint Cloud Minnesota
United States HealthEast St. Joseph's Hospital Saint Paul Minnesota
United States University of Utah Hospital and Clinics Salt Lake City Utah
United States University of California - San Diego-N San Diego California
United States Cox Health Springfield Missouri
United States St. John's hospital Springfield Illinois
United States University Community Hospital Tampa Florida
United States University of Texas Houston Health Science Center The Woodlands Texas
United States The Toledo Hospital Toledo Ohio
United States North Mississippi Medical Center Tupelo Mississippi
United States Trinity Mother Frances Health System Tyler Texas
United States PeaceHealth Southwest Medical Vancouver Washington
United States John Muir Medical Center Walnut Creek California

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium,  Germany,  Hong Kong,  Israel,  Italy,  Malaysia,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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