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

NCT04025710 NA COMPLETED Results posted

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.

Details

Lead sponsor	Biotronik SE & Co. KG
Phase	NA
Status	COMPLETED
Enrolment	167
Start date	Thu Oct 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Apr 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

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

Interventions

• BIOMONITOR III and BIOMONITOR IIIm

Countries

Denmark, Austria, Germany, Switzerland, Australia, Spain