RecruitingNot Applicable

Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Australia, Czechia, France1,400 participantsStarted 2019-10-28

Plain-language summary

This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.

Who can participate

Age range

18 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 intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM) * Patient is able to understand the nature of the registry and to provide written informed consent. * Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept. Exclusion Criteria: * Patient is pregnant or breast feeding. * Patient is less than 18 years old. * Patient is participating in another interventional clinical investigation other than the submodules of BIO\|STREAM.ICM

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

Time to diagnosis

Timeframe: The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.

Trial details

NCT IDNCT04075084

SponsorBiotronik SE & Co. KG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-05-30

Contact for this trial

Sabrina Hoche, Dr.

+49 30 68905 biomonitor-registry@biotronik.com

View on ClinicalTrials.gov More Tachycardia trials