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

Not Applicable

Completed

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Thoracic MRI Scan with 1.5 Tesla MRI	Thoracic MRI Scan	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.
Thoracic MRI Scan with 3 Tesla MRI	Thoracic MRI Scan	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System	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.

Secondary Outcome Measures

Name	Time	Method

Locations (20): Medanta-The Medicity
🇮🇳
Gurgaon, Haryana, India
Post Graduate Institute of Medical Education & Research
🇮🇳
Chandigarh, India
BLK Super Speciality Hospital
🇮🇳
Delhi, India
Max Super Specialty Hospital
🇮🇳
Delhi, India
Pushpawati Singhania Research Institute
🇮🇳
Delhi, India
Batra Hospital & Medical Research Centre
🇮🇳
Delhi, India
Fortis Flt. Lt. Rajan Dhall Hospital
🇮🇳
Delhi, India
National Heart Institute
🇮🇳
Delhi, India
Medanta Medicity Hospital
🇮🇳
Gurgaon, India
Care Hospital
🇮🇳
Hyderabad, India
Asian Heart Institute
🇮🇳
Mumbai, India
Escorts Heart Institute and Research Centre
🇮🇳
New Delhi, India
Seoul National University Hospital
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Seoul, Korea, Republic of
Dankook University Hospital
🇰🇷
Cheonan, Korea, Republic of
Cha Bundang Medical Center
🇰🇷
Seongnam-si, Korea, Republic of
Seoul St. Mary Hospital
🇰🇷
Seoul, Korea, Republic of
Severance Hospital
🇰🇷
Seoul, Korea, Republic of
Apollo Gleneagles Hospital
🇮🇳
Delhi, India
Hospital Serdang
🇲🇾
Kajang, Malaysia
Ruby Hall Clinic
🇮🇳
Pune, India