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Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment — CAPRI  

Bradycardia Clinical Trial

Official title:
Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment

Clinical Trial Summary

The interest of the CAPRI study is to confirm the safety and the efficacy of the ENO/TEO/OTO pacing system when used under 1.5 or 3 Tesla MRI environment and in accordance with the MRI solutions guideline.

Clinical Trial Description

The purpose of CAPRI study is to confirm the safety and the efficacy of the CE marked MR conditional pacing system composed of the ENO, TEO or OTO pacemaker with VEGA pacing lead(s). Conditions to undergo an MRI scan are provided in the MRI solutions guideline. The primary objective is to confirm the clinical safety of the ENO/TEO/OTO pacing system when used under 1.5 and 3 Tesla specific MRI conditions without scan exclusion zone. The study secondary main objectives are aiming to assess the performance of the MR conditional pacing system in the right atrium and ventricle at 1 month following the MRI scan: - Stability of the Pacing Capture Threshold - Stability of the lead sensed amplitude ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03811691
Study type Interventional
Source MicroPort CRM
Contact Anne RousseauPlasse
Phone 01 46 01 30 82
Email Anne.RousseauPlasse@crm.microport.com
Status Recruiting
Phase Phase 4
Start date July 18, 2019
Completion date August 2023
View Details
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