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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03012568
Other study ID # SJM-CIP-10137
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 10, 2016
Est. completion date March 29, 2018

Study information

Verified date August 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a clinical investigational plan (CIP) for the "Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems (ASSURE MRI)". This study intends to enroll patients who meet standard bradycardia or tachycardia indications and have already been implanted with one of the SJM device/lead combinations listed in this protocol. The objective of this study is to confirm the safety and effectiveness of each of the four SJM device/lead combinations in an MRI environment. This clinical investigation is sponsored by St. Jude Medical.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
SJM Implantable cardiac devices
SJM implantable devices undergoing MRI scan

Locations

Country Name City State
Australia Heart Care Partners - Wesley Hospital Auchenflower Queensland
Australia Heart Care Western Australia Perth Western Australia
India CARE Banjara Hyderabad Andhra Pradesh

Sponsors (1)

Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Australia,  India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Endpoint: Freedom from MRI scan-related complications One month following the MRI scan.
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