CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 167 enrolled
Drug / intervention
BIOMONITOR III and BIOMONITOR IIImdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04025710
NCT04025710N/ACompleted
CompareCT.gov

BIO|MASTER.BIOMONITOR III

Biotronik SE & Co. KG·interventional·Posted Jul 19, 2019·Updated Nov 27, 2024

In Brief

A clinical study evaluating BIOMONITOR III and BIOMONITOR IIIm for Tachyarrhythmia and 3 related conditions. Completed, enrolled 167 participants across 27 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTachyarrhythmia, Atrial Fibrillation (AF), Syncope, Cryptogenic Stroke
CountriesAustralia, Austria, Denmark, Germany, Spain, Switzerland
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 19, 2019
Enrollment StartOct 17, 2019
Primary CompletionJun 30, 2021
Study CompletionApr 6, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 7.0 years ago

Interventions

BIOMONITOR III and BIOMONITOR IIImdevice

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