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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

Brief Summary:
to assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.

Condition or disease Intervention/treatment Phase
ICD Tachycardia Radiation: Thoracic MRI Scan Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Study Start Date : October 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02877693


Contacts
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Contact: Louise Yim +852 2996 7605 lyim@sjm.com
Contact: Sumit Anand +91 11 42600161 sanand@sjm.com

Locations
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India
Escorts Heart Institute and Research Centre Recruiting
New Delhi, India
Contact: Kler Tarlochan         
Principal Investigator: Kler Tarlochan         
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Director: Grant Kim St. Jude Medical, Inc.

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02877693     History of Changes
Other Study ID Numbers: SJM-CIP-10163
First Posted: August 24, 2016    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Abbott Medical Devices:
ICD
Thoracic MRI Scan
tachycardia
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes