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

Tachycardia Clinical Trial

— ASIA MRI ICD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877693
• Other study ID #: SJM-CIP-10163
• Status: Completed
• Phase: N/A
• Start date: October 10, 2016
• Est. completion date: March 23, 2020

Study information

• Verified date: March 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the clinical performance of the St. Jude Medical™ MR Conditional ICD System in patients undergoing an elective thoracic MRI scan.

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 information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 23, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• ICD
• Tachycardia

Intervention

Radiation:
• Thoracic MRI Scan
The ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

India,  Korea, Republic of,  Malaysia, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Average Specific Absorption Rate (SAR)	The average Specific Absorption Rate (SAR) during the MRI scan	MRI scan visit
Other	Number of Participants With Freedom From MRI-scan Related Complications* Related to St. Jude Medical™ MR Conditional ICD System	This proportion was calculated as the number of subjects who had high voltage leads with capture threshold increases of = 0.5V @ 0.5 ms from pre MRI scan testing to 1-month post MRI scan testing divided by total number of subjects who had high voltage lead implanted, underwent an MRI scan and had both pre-MRI scan and 1-month post MRI scan capture threshold measurements available.	from MRI scan visit to 1-month post MRI scan visit
Other	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	This proportion was calculated as the number of subjects who had high voltage leads with sensing amplitude decrease of = 50% from pre MRI scan testing to 1 month post MRI scan testing divided by the total number of subjects who had high voltage lead implanted, underwent an MRI scan and had both pre MRI scan and 1 month post MRI scan sensing amplitudes available.	from pre MRI scan to 1-month post MRI scan
Other	The Peak Specific Absorption Rate (SAR) During the MRI Scan	The peak Specific Absorption Rate (SAR) during the MRI scan	MRI Scan Visit
Other	The Mean MRI Visit Duration in the MRI Lab	The mean MRI visit duration in the MRI lab	MRI Visit
Other	Total MRI Scan Duration in MRI Laboratory	Total MRI scan duration in MRI laboratory	MRI Visit
Primary	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.	from MRI scan visit to 1 month post-MRI scan visit