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A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging (ASIA MRI ICD)

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ClinicalTrials.gov Identifier: NCT02877693
Recruitment Status : Recruiting
First Posted : August 24, 2016
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE August 19, 2016
First Posted Date  ICMJE August 24, 2016
Last Update Posted Date March 14, 2017
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2016)
Freedom from MRI-scan related complications* related to St. Jude Medical™ MR Conditional ICD System [ Time Frame: from MRI scan visit to 1 month post-MRI scan visit ]
*A complication is a serious adverse device effect (SADE) that requires an invasive intervention or leads to death. The primary endpoint analysis will be performed for each study phase separately.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02877693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Official Title  ICMJE A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Brief Summary to assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.
Detailed Description

This clinical investigation is a prospective, multicenter, 2-phase, single arm, Asian study.

  • In the 1st phase patients will be enrolled within 60 days of implant with a St. Jude Medical™ MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines.
  • In the 2nd phase patients will be enrolled within 60 days of implant with a St. Jude Medical™ MR Conditional ICD System approved* for thoracic scan with 3.0 Tesla MRI scanning machines.

    • NOTE: The 2nd phase of this study will start only after receiving appropriate regulatory approval for MRI labelling at 3.0T and phase 1 enrollment has completed
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • ICD
  • Tachycardia
Intervention  ICMJE Radiation: Thoracic MRI Scan
is to demonstrate the MRI scan will not adversely affect the functionality of the ICD system. To do so, the ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized.
Study Arms  ICMJE Thoracic MRI Scan
Subjects will be enrolled within 60 days of successful St. Jude Medical™ MR Conditional ICD System implant or within 60 days post most recent lead revision (if applicable) whichever is latter. Enrolled subjects will undergo an elective MRI scan from 60-90 days of implant or most recent lead revision (if applicable) whichever is latter. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
Intervention: Radiation: Thoracic MRI Scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2016)
396
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System within 60 days
  2. Subject is willing to undergo an elective MRI scan without sedation NOTE: Antianxiety agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can communicate with site personnel during the MRI scan
  3. Subject's ventricular bipolar capture threshold is stable < 2.5V @ 0.5ms
  4. Subject's ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sensing amplitude is > 4mV
  5. Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
  6. Subject is willing and able to comply with the prescribed follow-up tests and procedures
  7. Subject is not contraindicated for an MRI scan (per the MRI Screening Form)

Exclusion Criteria:

  1. Subject is pacemaker dependent
  2. Subject has a non SJM MRI compatible endocardial lead implanted or capped
  3. Subject has another existing active implanted medical device, e.g., neurostimulator, infusion pump, etc. that has MR labeling that will not allow the MRI scans per this protocol to be completed.
  4. Subject has a high voltage lead revision incidence within 60 days of the enrollment visit
  5. Subject has other non-MRI compatible device or material implanted NOTE: MRI compatible knee replacements, hip replacements, stents, etc. may be included as long as the labeling of these devices allow MRI scans conducted per this protocol NOTE: MRI compatible mechanical, prosthetic, and bioprosthetic heart valves may be included as long as the labeling of these devices allow for MRI scans conducted per this protocol NOTE: Non-removable dental implants may be included
  6. Subject has a lead extender, adaptor, or capped/abandoned lead
  7. Subject is enrolled or intend to participate in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug or additional testing beyond standard of care procedures), which could confound the results of this trial as determined by SJM.
  8. Subject is pregnant or planning to become pregnant during the duration of the subject's participation in the study
  9. Subject has a life expectancy of less than 12 months due to any condition
  10. Subject has exclusion criteria required by local law (e.g., age)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Louise Yim +852 2996 7605 lyim@sjm.com
Contact: Sumit Anand +91 11 42600161 sanand@sjm.com
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02877693
Other Study ID Numbers  ICMJE SJM-CIP-10163
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Grant Kim St. Jude Medical, Inc.
PRS Account Abbott Medical Devices
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP