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BIO|MASTER.Edora Family Study

NCT03091322 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2020-05-12

No results posted yet for this study

Summary

This study is designed as post market clinical follow-up study with CE-marked products to evaluate the AV Opt and LV VectorOpt features in the respective Edora family pacemakers under clinical conditions. Furthermore, adverse events will be evaluated to identify residual risks associated with the use of the BIOTRONIK Edora family pacemakers. The study is further designed to address potential regulatory needs of clinical data for countries and regions not covered by the CE approval.

Conditions

  • Pacemaker Therapy
  • Cardiac Resynchronization Therapy

Interventions

DEVICE

Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8

Assessment of the AV Opt and LV VectorOpt features

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-12
Primary Completion
2019-09-12
Completion
2019-12-02

Countries

  • Austria
  • Germany
  • Spain
  • Switzerland

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 NCT03091322 on ClinicalTrials.gov