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

NCT02877693 | Completed Results

• 1 other identifier: SJM-CIP-10163
• Study Type: interventional
• Target: 205
• Locations: 3 countries
• Sites: 20

Brief Summary

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

Conditions

ICD; Tachycardia

Keywords

ICD; Thoracic MRI Scan; tachycardia

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (6)

• The Average Specific Absorption Rate (SAR)

  MRI scan visit

• 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

• 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

  from pre MRI scan to 1-month post MRI scan

Study Arms (2)

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.

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.

Radiation: Thoracic MRI Scan

Interventions

Thoracic MRI Scan 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 1.5 Tesla MRI; Thoracic MRI Scan with 3 Tesla MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (20)

Medanta-The Medicity

Gurgaon, Haryana, 122001, India

Location

Post Graduate Institute of Medical Education & Research

Chandigarh, 160012, India

Location

BLK Super Speciality Hospital

Delhi, 110005, India

Location

Max Super Specialty Hospital

Delhi, 110017, India

Location

Pushpawati Singhania Research Institute

Delhi, 110017, India

Location

Apollo Gleneagles Hospital

Delhi, India

Location

Batra Hospital & Medical Research Centre

Delhi, India

Location

Fortis Flt. Lt. Rajan Dhall Hospital

Delhi, India

Location

National Heart Institute

Delhi, India

Location

Medanta Medicity Hospital

Gūrgaon, 122001, India

Location

Care Hospital

Hyderabad, 500034, India

Location

Asian Heart Institute

Mumbai, 400051, India

Location

Escorts Heart Institute and Research Centre

New Delhi, India

Location

Ruby Hall Clinic

Pune, 411001, India

Location

Hospital Serdang

Kajang, Malaysia

Location

Dankook University Hospital

Cheonan, South Korea

Location

Cha Bundang Medical Center

Seongnam-si, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Seoul St. Mary Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The 3T MRI part of the study was not completed as the study was terminated upon completion of the 1.5T MRI part of the study

Results Point of Contact

• Title: Grant Kim, Director Clinical Programs
• Organization: Abbott

grant.kim1@abbott.com

818-493-3147

Study Officials

• Grant Kim

  St. Jude Medical, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 24, 2016
• Study Start: October 10, 2016
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: December 8, 2023
• Results First Posted: December 8, 2023

Record last verified: 2023-03

Locations

IN (14); MY (1); KR (5)