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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)

Primary Purpose

ICD, Tachycardia

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Thoracic MRI Scan
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for ICD focused on measuring ICD, Thoracic MRI Scan, tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System for at least 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 stable > 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 < 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)

Sites / Locations

  • Medanta-The Medicity
  • Post Graduate Institute of Medical Education & Research
  • BLK Super Speciality Hospital
  • Max Super Specialty Hospital
  • Pushpawati Singhania Research Institute
  • Apollo Gleneagles Hospital
  • Batra Hospital & Medical Research Centre
  • Fortis Flt. Lt. Rajan Dhall Hospital
  • National Heart Institute
  • Medanta Medicity Hospital
  • Care Hospital
  • Asian Heart Institute
  • Escorts Heart Institute and Research Centre
  • Ruby Hall Clinic
  • Dankook University Hospital
  • Cha Bundang Medical Center
  • Seoul National University Hospital
  • Seoul St. Mary Hospital
  • Severance Hospital
  • Hospital Serdang

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Thoracic MRI Scan

Arm Description

Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.

Outcomes

Primary Outcome Measures

Freedom from MRI-scan related complications* related to St. Jude Medical™ MR Conditional ICD System
*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.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2016
Last Updated
January 13, 2021
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT02877693
Brief Title
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Acronym
ASIA MRI ICD
Official Title
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2016 (Actual)
Primary Completion Date
March 23, 2020 (Actual)
Study Completion Date
March 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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,single arm, Asian study. - Patients will be enrolled at least 60 days post successful implant with a St. Jude Medical™ MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICD, Tachycardia
Keywords
ICD, Thoracic MRI Scan, tachycardia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thoracic MRI Scan
Arm Type
Other
Arm Description
Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit.
Intervention Type
Radiation
Intervention Name(s)
Thoracic MRI Scan
Intervention Description
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 Measure Information:
Title
Freedom from MRI-scan related complications* related to St. Jude Medical™ MR Conditional ICD System
Description
*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.
Time Frame
from MRI scan visit to 1 month post-MRI scan visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is pectorally implanted with St. Jude Medical™ MR Conditional ICD System for at least 60 days 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 Subject's ventricular bipolar capture threshold is stable < 2.5V @ 0.5ms Subject's ventricular sensing is measurable (patient has underlying rhythm > 30bpm) and the sensing amplitude is stable > 4mV Subject is able to provide informed consent for study participation (legal guardian or legally authorized representative is NOT acceptable) Subject is willing and able to comply with the prescribed follow-up tests and procedures Subject is not contraindicated for an MRI scan (per the MRI Screening Form) Exclusion Criteria: Subject is pacemaker dependent Subject has a non SJM MRI compatible endocardial lead implanted or capped 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. Subject has a high voltage lead revision incidence < 60 days of the enrollment visit 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 Subject has a lead extender, adaptor, or capped/abandoned lead 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. Subject is pregnant or planning to become pregnant during the duration of the subject's participation in the study Subject has a life expectancy of less than 12 months due to any condition Subject has exclusion criteria required by local law (e.g., age)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grant Kim
Organizational Affiliation
St. Jude Medical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Medanta-The Medicity
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
Post Graduate Institute of Medical Education & Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Facility Name
BLK Super Speciality Hospital
City
Delhi
ZIP/Postal Code
110005
Country
India
Facility Name
Max Super Specialty Hospital
City
Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Pushpawati Singhania Research Institute
City
Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Apollo Gleneagles Hospital
City
Delhi
Country
India
Facility Name
Batra Hospital & Medical Research Centre
City
Delhi
Country
India
Facility Name
Fortis Flt. Lt. Rajan Dhall Hospital
City
Delhi
Country
India
Facility Name
National Heart Institute
City
Delhi
Country
India
Facility Name
Medanta Medicity Hospital
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Care Hospital
City
Hyderabad
ZIP/Postal Code
500034
Country
India
Facility Name
Asian Heart Institute
City
Mumbai
ZIP/Postal Code
400051
Country
India
Facility Name
Escorts Heart Institute and Research Centre
City
New Delhi
Country
India
Facility Name
Ruby Hall Clinic
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Dankook University Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Cha Bundang Medical Center
City
Seongnam-si
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Hospital Serdang
City
Kajang
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
Tarlochan Singh Kler, Praveen Chandra, Chandrakant Chavan, Rajesh Vijayvergiya, Subhash Chandra, Anoop Gupta, Sridevi Chennapragada, Joung Bo Young, Mona Bhatia, Choi Eue Keun, Vanita Arora, Tom Devasia, Upendra Kaul, Sumit Anand, Kartikeya Bhargava. Initial experience of thoracic Magnetic Resonance Imaging (MRI) scanning in Asian patients implanted the Ellipse MR Conditional ICD System - The ASIA MRI ICD Study. APHRS 2017; Abstract no. 40528.
Results Reference
background

Learn more about this trial

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

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