NCT03811691

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: MicroPort CRM · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Bradycardia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI exam	Pacing system safety and stability under MRI scan environment

Timeline

• Start date: 2019-07-18
• Primary completion: 2021-12-01
• Completion: 2023-08-01
• First posted: 2019-01-22
• Last updated: 2021-06-09

Locations

1 site across 1 country: France