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

NCT03811691 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2021-06-09

No results posted yet for this study

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.

Conditions

  • Bradycardia

Interventions

DIAGNOSTIC_TEST

MRI exam

Pacing system safety and stability under MRI scan environment

Sponsors & Collaborators

  • MicroPort CRM

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2021-12-31
Completion
2023-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03811691 on ClinicalTrials.gov