ICDASIA MRI ICDNCT02877693
A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
A study testing Thoracic MRI Scan in people with ICD and Tachycardia, run by Abbott Medical Devices at 20 sites in 3 countries.
Trial summary
To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICD, Tachycardia
- What is being tested?
- Thoracic MRI Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 10 Oct 2016to 23 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
India14 sites
Post Graduate Institute of Medical Education & Research
Chandigarh, 160012
BLK Super Speciality Hospital
Delhi, 110005
Max Super Specialty Hospital
Delhi, 110017
Pushpawati Singhania Research Institute
Delhi, 110017
Apollo Gleneagles Hospital
Delhi
Batra Hospital & Medical Research Centre
Delhi
Fortis Flt. Lt. Rajan Dhall Hospital
Delhi
National Heart Institute
Delhi
Medanta-The Medicity
Gurgaon, Haryana, 122001
Medanta Medicity Hospital
Gūrgaon, 122001
Care Hospital
Hyderabad, 500034
Asian Heart Institute
Mumbai, 400051
Escorts Heart Institute and Research Centre
New Delhi
Ruby Hall Clinic
Pune, 411001
South Korea5 sites
Dankook University Hospital
Cheonan
Cha Bundang Medical Center
Seongnam-si
Seoul National University Hospital
Seoul
Seoul St. Mary Hospital
Seoul
Severance Hospital
Seoul
About this study
To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.
Read the detailed description
This clinical investigation is a prospective, multicenter, Asian study. The study was designed with two (2) parts, however only the 1st part was completed. For the 1st part, patients were enrolled with a SJM MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines. The 2nd part-meant to enroll patients for thoracic scans with 3 Tesla MRI scanning machines-was not completed.
- Conditions
- ICD, Tachycardia
- Being tested
- Thoracic MRI Scan
- Keywords
- ICD, Thoracic MRI Scan, tachycardia
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic MRI ScanRadiation
The ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic MRI Scan with 1.5 Tesla MRI | Experimental | Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit. Receives: Radiation: Thoracic MRI Scan |
| Thoracic MRI Scan with 3 Tesla MRI | Experimental | Subjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 3T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit. Receives: Radiation: Thoracic MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 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.
Measured: from MRI scan visit to 1 month post-MRI scan visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start10 Oct 2016
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ICDStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grant Kim, Study director, St. Jude Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877693
- Sponsor's protocol ID
- SJM-CIP-10163
- Acronym
- ASIA MRI ICD
- Status last verified
- Mar 2023
- First submitted
- 19 Aug 2016
- Last updated
- 8 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02877693
- Acronym / sponsor ID
- ASIA MRI ICD / SJM-CIP-10163
- Conditions
- ICD, Tachycardia
- Keywords
- ICD, Thoracic MRI Scan, tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 24 Aug 2016 (estimated)
- Results
- Posted 8 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, Asian study. The study was designed with two (2) parts, however only the 1st part was completed. For the 1st part, patients were enrolled with a SJM MR Conditional ICD System approved for thoracic scan with 1.5 Tesla MRI scanning machines. The 2nd part-meant to enroll patients for thoracic scans with 3 Tesla MRI scanning machines-was not completed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracic MRI Scan with 1.5 Tesla MRI | Experimental | Radiation: Thoracic MRI ScanSubjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 1.5T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit. |
| Thoracic MRI Scan with 3 Tesla MRI | Experimental | Radiation: Thoracic MRI ScanSubjects will be enrolled at least 60 days post successful St. Jude Medical™ MR Conditional ICD System implant. Enrolled subjects will undergo an elective 3T MRI scan within 30 days post enrollment. Post MRI visit all subjects will be followed up at 1-Month post MRI visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic MRI ScanThe ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized. | Radiation | Thoracic MRI Scan with 1.5 Tesla MRI, Thoracic MRI Scan with 3 Tesla MRI |
Primary outcome
Number of Participants With 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundTarlochan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant Kim study director
St. Jude Medical, Inc.
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic MRI Scan in people with ICD and Tachycardia, run by Abbott Medical Devices at 20 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in India, South Korea, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02877693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.