NCT03451721

Observation of ImageReady™ MR Conditional Defibrillation System in China

Observation of ImageReady™ MR Conditional Defibrillation System in China (MR ICD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Arrhythmia

Interventions

Type	Name	Description
DEVICE	ImageReady™ MR Conditional Defibrillation System	Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD

Timeline

• Start date: 2018-04-03
• Primary completion: 2019-03-12
• Completion: 2019-12-10
• First posted: 2018-03-02
• Last updated: 2021-11-01
• Results posted: 2020-04-24

Locations

1 site across 1 country: China