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BIO|MASTER.Ilivia Family / Plexa

NCT02774616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2019-05-22

Study results available
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Summary

Post-Market Clinical Follow-up of the new Ilivia ICD Family and the new Plexa right ventricular lead to fulfill requirements by the notified body and to support regulatory approval outside of the CE region

Conditions

Interventions

DEVICE

Ilivia ICD Family

pre-defined device programming, measurements and follow-up schedule

DEVICE

Plexa ICD lead

predefined follow-up schedule

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Christian Sticherling, Prof. Dr. · Universitätsspital Basel

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-12-31
Completion
2018-03-31

Countries

  • Australia
  • Austria
  • Denmark
  • France
  • Germany
  • Israel
  • Latvia
  • Singapore
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT02774616 on ClinicalTrials.gov