An observational study in Tachycardia, Atrial Fibrillation and Syncope, sponsored by Biotronik SE & Co. KG. Recruiting at 31 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Biotronik SE & Co. KG · Observational
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.
189 studies on the registry are indexed under Tachycardia; 24 are open to participants now.
This study's planned enrollment of 1,400 is above the median of 200 across 62 observational studies indexed under Tachycardia.
Browse Tachycardia studies →Biotronik SE & Co. KG is the lead sponsor of 83 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The intended patient population consists of all patients who would benefit from long-term cardiac rhythm monitoring.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Time to diagnosis
Device is intended to detect rare arrhythmias. Time to detect this relevant arrhythmia will be recorded.
Time frame: The time to a relevant diagnosis can vary significantly. The time period starts with the insertion of the device.
Insertion procedure and success
Information on the insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and insertion tool); Success rate of insertions.
Time frame: Data on BIOMONITOR insertion procedure and success rate are collected at day of insertion.
Sensing and noise
Quality of sensing Amplitude (Millivolt) and electrical noise (%) detected by the BIOMONITOR.
Time frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Inspection results of the insertion site
Rating of wound healing and cosmetic outcome by the physician/patient (5-level scale).
Time frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Patient contentment regarding BIOMONITOR wearability
Patients opinion about the wearing comfort (5-level-scale).
Time frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Device migration
Assessement whether the BIOMONITOR migrates under the skin.
Time frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Diagnosis and clinical actions after arrhythmia detection
Documentation whether the BIOMONITOR helps to detect arrhythmias. Documentation of therapies used to treat these arrhythmias and whether the BIOMONITOR helps to monitor therapy success.
Time frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Explantation / deactivation / exchange information of the BIOMONITOR
Collect information about explantation, deactivation and exchanges of the BIOMONITOR, such as number, reason, and data on procedure.
Time frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Adverse Events
Collect and analyze adverse events.
Time frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Device Deficiencies
Collect and analyze device deficiencies. Calculate rate (frequency) of device deficiencies.
Time frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
Documentation of imaging techniques, if applied.
Documentation if patients underwent any MRI examinations or mammography. Documentation of exact kind of examination and occurrences with regard to the BIOMONITOR.
Time frame: Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out).
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Started Oct 2019 (actual). Primary completion is estimated for May 2027, 91 months after the start.
Of 27 observational studies under Tachycardia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's planned 91 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.