NCT03261063

China Evera MRI® Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, single arm, non-blinded, multi-site study conducted in mainland China.

Detailed description

The purpose of the China Evera MRI® study is to confirm safety of the Evera MRI ICD System in the clinical MRI (Magnetic Resonance Imaging) environment when subjects receive MRI scans up to 2W/kg Specific Absorption Rate (SAR) without positioning restrictions (MRI scans may occur anywhere on the body). Long-term device effects, such as long-term lead integrity, will not be assessed in the China Evera MRI® study.

Conditions

• Arrhythmias, Cardiac

Interventions

Type	Name	Description
DEVICE	Evera MRI ICD System	Subjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements

Timeline

• Start date: 2017-10-12
• Primary completion: 2018-09-26
• Completion: 2018-09-26
• First posted: 2017-08-24
• Last updated: 2018-10-15

Locations

3 sites across 1 country: China