Master Study of the BIOMONITOR III and Incision and Insertion Tool (FIT OneStep)
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|ClinicalTrials.gov Identifier: NCT04025710|
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : September 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tachyarrhythmia Atrial Fibrillation (AF) Syncope Cryptogenic Stroke||Device: BIOMONITOR III and BIOMONITOR IIIm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||157 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||BIO|MASTER.BIOMONITOR III|
|Actual Study Start Date :||October 17, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2022|
Device: BIOMONITOR III and BIOMONITOR IIIm
- SADE-free rate until the 3-month follow-up [ Time Frame: 3 months ]SADE-free rate related to BIOMONITOR III and BIOMONITOR IIIm including incision and insertion tool set until 3-month follow-up
- R-wave amplitude [ Time Frame: 10 days to 4 weeks after insertion; 3-months ]The secondary endpoint 1 evaluates the R-wave amplitude at the 1st follow-up and at 3-month follow-up by measuring both, the lowest and the highest amplitude value via the programmer.
- Noise burden [ Time Frame: 10 days to 4 weeks after insertion; 3-months ]The secondary endpoint 2 evaluates the noise burden at the 1st follow-up and at 3-month follow-up by retrieving the percentage of noise via the programmer.
- Assessment of P-wave visibility [ Time Frame: 10 days to 4 weeks after insertion; 3-months ]The secondary endpoint 3 evaluates the P-wave visibility at 1st, 3- and 12-month follow-up. The investigator will evaluate whether P-waves can be recognized in the stored sECGs showing sinus rhythm. The number of heart cycles and observed P-waves which can undoubtly be identified in ECGs will be assessed by the investigator.
- SADE-free rate until the 12-month follow-up [ Time Frame: 12-months ]The secondary endpoint 4 is the SADE-free rate related to the BIOMONITOR III and BIOMONITOR IIIm 12 months after insertion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04025710
|Contact: Anja Viehrig, Dr.||+49 (0) 30 email@example.com|
|Contact: Gabriel Knop-Sedmak||+49 (0) 30 firstname.lastname@example.org|
|Principal Investigator:||Thomas Deneke, Prof. Dr.||RHÖN-KLINIKUM Campus Bad Neustadt, Germany|