Clinical trial NCT02877693: A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Official title: A Post-market Clinical Evaluation of St. Jude Medical™ MR Conditional ICD System on Patients Undergoing Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICD
Tachycardia
Keywords: ICD
Thoracic MRI Scan
tachycardia
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-08-24
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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, 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System
timeFrame: from MRI scan visit to 1 month post-MRI scan visit
Secondary outcomes:
Other outcomes:
measure: The Average Specific Absorption Rate (SAR)
timeFrame: MRI scan visit
measure: Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System
timeFrame: from MRI scan visit to 1-month post MRI scan visit
measure: Proportion of SJM High Voltage Lead Implanted With SJM MR Conditional ICD With Sensing Amplitude Decrease of ≤ 50% From Pre-MRI Scan Testing to 1 Month Post-MRI Scan Testing
timeFrame: from pre MRI scan to 1-month post MRI scan
measure: The Peak Specific Absorption Rate (SAR) During the MRI Scan
timeFrame: MRI Scan Visit
measure: The Mean MRI Visit Duration in the MRI Lab
timeFrame: MRI Visit
measure: Total MRI Scan Duration in MRI Laboratory
timeFrame: MRI Visit
Locations:
city: Gurgaon
country: India
facility: Medanta-The Medicity
state: Haryana
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education & Research
city: Delhi
country: India
facility: BLK Super Speciality Hospital
city: Delhi
country: India
facility: Max Super Specialty Hospital
city: Delhi
country: India
facility: Pushpawati Singhania Research Institute
city: Delhi
country: India
facility: Apollo Gleneagles Hospital
city: Delhi
country: India
facility: Batra Hospital & Medical Research Centre
city: Delhi
country: India
facility: Fortis Flt. Lt. Rajan Dhall Hospital
city: Delhi
country: India
facility: National Heart Institute
city: Gurgaon
country: India
facility: Medanta Medicity Hospital
city: Hyderabad
country: India
facility: Care Hospital
city: Mumbai
country: India
facility: Asian Heart Institute
city: New Delhi
country: India
facility: Escorts Heart Institute and Research Centre
city: Pune
country: India
facility: Ruby Hall Clinic
city: Cheonan
country: Korea, Republic of
facility: Dankook University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Cha Bundang Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Kajang
country: Malaysia
facility: Hospital Serdang
Study officials:
affiliation: St. Jude Medical, Inc.
name: Grant Kim
role: STUDY_DIRECTOR
References:
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.