CompletedNot Applicable

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

Australia, Austria, Denmark167 participantsStarted 2019-10-17

Plain-language 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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient is at high risk of developing a clinically important cardiac arrhythmia; or * Patient is undergoing investigation for symptoms such as palpitations, pre- syncope or syncope, that are suggestive of an underlying cardiac arrhythmia; or * Patient is undergoing investigation for the detection of atrial fibrillation following cryptogenic stroke; or * Patient is planned for AF ablative procedure or has already undergone an AF ablative procedure. * Patient is able to understand the nature of the study and able to provide written informed consent. * Patient is willing and able to perform all follow-up visits at the investigational site. * Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept. Exclusion Criteria: * Patient is implanted with an ICD or pacemaker. * Patient is pregnant or breast-feeding. * Patient is less than 18 years old. * Patient's life-expectancy is less than 12 months. * Patient is participating in another interventional clinical investigation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

SADE-free Rate Until the 3-month Follow-up

Timeframe: 3 months

Trial details

NCT IDNCT04025710

SponsorBiotronik SE & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-30

Results submitted2023-04-03

View on ClinicalTrials.gov More Tachyarrhythmia trials