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

NCT ID: NCT02877693

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-10
• Study Completion Date: 2020-03-23

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.

Conditions

ICD; Tachycardia

Keywords

ICD; Thoracic MRI Scan; tachycardia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Thoracic MRI Scan with 1.5 Tesla MRI

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.

Group Type: EXPERIMENTAL

Thoracic MRI Scan

Intervention Type: RADIATION

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

Thoracic MRI Scan with 3 Tesla MRI

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.

Group Type: EXPERIMENTAL

Thoracic MRI Scan

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grant Kim

Role: STUDY_DIRECTOR

St. Jude Medical, Inc.

Locations

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

Apollo Gleneagles Hospital

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

Ruby Hall Clinic

Pune, , India

Hospital Serdang

Kajang, , Malaysia

Dankook University Hospital

Cheonan, , South Korea

Cha Bundang Medical Center

Seongnam-si, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Seoul St. Mary Hospital

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

Countries

India; Malaysia; South Korea

References

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.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SJM-CIP-10163

Identifier Type: -

Identifier Source: org_study_id