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China (CN)_Magnetic Resonance Imaging (MRI)_Implantable Cardiac Defibrillator (ICD) [CN_MRI_ICD] (CN_MRI_ICD)

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ClinicalTrials.gov Identifier: NCT03828357
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
This clinical study is to evaluate the safety and effectiveness of the Ellipse VR/DR and Fortify Assura VR/DR implantable cardiac defibrillators (ICDs), with Durata or Optisure High Voltage (HV) defibrillation leads and Tendril STS or Isoflex Low Voltage (LV) leads in a 1.5T MRI environment for MR-conditional labeling expansion of these market-approved ICD systems in China.

Condition or disease Intervention/treatment
Tachycardia Other: Study MRI scan

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Evaluation of ICD Defibrillation Systems in a 1.5T Magnetic Resonance Imaging Environment in China
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Ellipse VR with Durata
Ellipse VR single-chamber ICD with a Durata High Voltage (HV) defibrillation lead
Other: Study MRI scan
At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.

Fortify Assura VR with Optisure
Fortify Assura VR single-chamber ICD, with an Optisure High Voltage (HV) defibrillation lead.
Other: Study MRI scan
At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.

Ellipse DR with Durata & Tendril STS
Ellipse DR dual-chamber ICD with a Durata High Voltage defibrillation lead in the right ventricle (RV) and a Tendril STS low voltage lead in the right atrium (RA).
Other: Study MRI scan
At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.

Fortify Assura DR with Optisure and Isoflex
Fortify Assura DR dual-chamber ICD with an Optisure High Voltage defibrillation lead in the right ventricle (RV) and an Isoflex low voltage lead in the right atrium (RA).
Other: Study MRI scan
At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.




Primary Outcome Measures :
  1. Safety outcomes: Freedom from Magnetic Resonance Imaging (MRI) scan related complications [ Time Frame: 1 month ]
    Freedom from Magnetic Resonance Imaging (MRI) scan related complications related to the Implantable Cardiac Difibrillator (ICD) device and/or leads from the time of the MRI scan to 1-month post-MRI scan testing.

  2. Effectiveness outcomes: Proportion of leads with a capture threshold increase [ Time Frame: 1 month ]
    Proportion of leads with a capture threshold increase of ≤ 0.5V at 0.5ms from pre-MRI scan to 1-month post-MRI scan testing.


Secondary Outcome Measures :
  1. Demographics: Gender [ Time Frame: 1 month ]
    Gender

  2. Demographics:Age [ Time Frame: 1 month ]
    Age

  3. Demographics: Ethnicity [ Time Frame: 1 month ]
    Ethnicity

  4. Demographics: Race [ Time Frame: 1 month ]
    Race

  5. Demographics: Medical History [ Time Frame: 1 month ]
    Cardiac disease history, arrhythmia history, indication for ICD implant, history of smoking, etc.

  6. Device electrical measurements [ Time Frame: 1 month ]
    Device electrical measurements at the MRI Scan Visit (pre- and post-scan) and at the 1 Month Post Scan Visit

  7. Number of Adverse Device Events (ADE) [ Time Frame: 1 month ]
    Collect the number of ADEs for analysis

  8. Number of Serious Adverse Device Events (SADE) [ Time Frame: 1 month ]
    Collect the number of SADEs for analysis

  9. Number of Unparticipated Serious Adverse Device Events (USADE) [ Time Frame: 1 month ]
    Collect the number of USADEs for analysis

  10. Number of Deaths [ Time Frame: 1 month ]
    Collect the number of ADEs for Mortality analysis

  11. Number of non-study MRI scans [ Time Frame: 1 month ]
    Number of non-study MRI scans

  12. The number of subjects that returned to usual programming [ Time Frame: 1 month ]
    The number of subjects that returned to usual programming after the MRI scan and number of subjects, if any, experiencing delays in reprogramming



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population includes male and female Chinese nationals that meet the eligibility requirements and give consent for the study. Vulnerable subjects, such as minors or those unable to provide consent are excluded from participating.
Criteria

Inclusion Criteria:

To participate in this clinical study, the subject must meet all of the following inclusion criteria:

  • Have an approved indication for implantation of a ICD
  • Be a Chinese national
  • Will be implanted with one of the following device/lead combinations evaluated in this study:

    • Group 1: Ellipse VR single-chamber ICD with a Durata lead in the right ventricle (RV)
    • Group 2: Fortify Assura single-chamber ICD, with an Optisure lead
    • Group 3: Ellipse DR dual-chamber ICD with a Durata lead in the RV and a Tendril STS lead in the right atrium (RA)
    • Group 4: Fortify Assura ICD and an Optisure lead in the RV and an Isoflex lead in the RA
  • Be willing to undergo an elective MRI scan without sedation ≥ 45 days after implant 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
  • Be able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable)
  • Be willing and able to comply with the prescribed follow-up tests and procedures
  • Are not contraindicated for an MRI scan (per the MRI Screening Form)
  • Subjects who are at least 18 years of age (or older, required by local law)

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation:

  • Have a competitor's MRI compatible endocardial lead implanted or capped
  • Have 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.
  • Have other non-MRI compatible device or material implanted. The following examples may be included as long as labelling of these devices allow MRI scans conducted per this protocol:

    • MRI compatible knee replacements, hip replacements, stents, etc.
    • MRI compatible mechanical, prosthetic, and bio prosthetic heart valves
    • Non-removable dental implants
  • Have a lead extender, adaptor, or capped/abandoned lead
  • 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 study as determined by Abbott.
  • Pregnant or planning to become pregnant during the duration of the subject's participation in the study
  • Have a life expectancy of less than 12 months due to any condition

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): NCT03828357


Contacts
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Contact: Xu Jin, Master +8613811791257 xu.jin1@abbott.com
Contact: Zilin Wang, Bachelor +862123067568 zilin.wang@abbott.com

Locations
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China, Zhejiang
The First Affiliated Hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Xiang Yin, MD         
Sponsors and Collaborators
Abbott Medical Devices

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03828357     History of Changes
Other Study ID Numbers: CRD_930
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This has not yet been decided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes