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Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)

NCT04025710 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2024-11-27

Study results available
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Summary

This study is a post-market clinical follow-up (PMCF) study to identify and evaluate residual risks associated with the use of the BIOMONITOR III and BIOMONITOR IIIm that are discovered or remain even after risk analysis, risk mitigation and successful conformity assessment. Furthermore, this study will also provide additional data as required by regulatory authorities outside of the CE-region.

Conditions

  • Tachyarrhythmia
  • Atrial Fibrillation (AF)
  • Syncope
  • Cryptogenic Stroke

Interventions

DEVICE

BIOMONITOR III and BIOMONITOR IIIm

* Insertion of BIOMONITOR III or BIOMONITOR IIIm * three scheduled in-office follow-ups * 48-hour Holter ECG

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Thomas Deneke, Prof. Dr. · RHÖN-KLINIKUM Campus Bad Neustadt, Germany

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2021-06-30
Completion
2022-04-06

Countries

  • Australia
  • Austria
  • Denmark
  • 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 NCT04025710 on ClinicalTrials.gov