Clinical Trials Directory

Trials / Completed

CompletedNCT04025710

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

BIO|MASTER.BIOMONITOR III

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
167 (actual)
Sponsor
Biotronik SE & Co. KG · Industry
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2019-10-17
Primary completion
2021-06-30
Completion
2022-04-06
First posted
2019-07-19
Last updated
2024-11-27
Results posted
2024-01-11

Locations

27 sites across 6 countries: Australia, Austria, Denmark, Germany, Spain, Switzerland

Source: ClinicalTrials.gov record NCT04025710. Inclusion in this directory is not an endorsement.