Observation of ImageReady™ MR Conditional Defibrillation System in China

Status Completed

Clinical Trial Summary

To observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.

Clinical Trial Description

This is a multi-center, prospective, single-arm study, aimed to observe the safety and effectiveness of ImageReady™ MR conditional defibrillation system in a Chinese population.It will enroll 20 subjects in 5 sites in China.The primary safety endpoint is MR scan-related Complication-free rate between the MR Scan and the MRI + 1 Month Visit. The primary effectiveness endpoints include:1.Abnormal increase in RV shocking impedance from the pre-MR scan to the 1 Month post-MR scan. 2.Increase in RV pacing threshold from the pre-MR scan to the 1 Month post-MR scan. 3.Decrease in RV sensed amplitude from the pre-MR scan to the 1 Month post-MR scan. 4.Increase in LV pacing threshold from the pre-MR scan to the 1 Month post-MR scan. 5.Decrease in LV sensed amplitude from the pre-MR scan to the 1 Month post- MR scan. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03451721
Study type	Interventional
Source	Boston Scientific Corporation
Contact
Status	Completed
Phase	N/A
Start date	April 3, 2018
Completion date	December 10, 2019

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