NCT04075084 Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)
| NCT ID | NCT04075084 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biotronik SE & Co. KG |
| Condition | Tachycardia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,400 participants |
| Start Date | 2019-10-28 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,400 participants in total. It began in 2019-10-28 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04075084 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tachycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04075084 currently recruiting?
Yes, NCT04075084 is actively recruiting participants. Contact the research team at biomonitor-registry@biotronik.com for enrollment information.
Where is the NCT04075084 trial being conducted?
This trial is being conducted at Adelaide, Australia, Adelaide, Australia, České Budějovice, Czechia, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT04075084 clinical trial?
NCT04075084 is sponsored by Biotronik SE & Co. KG. The trial plans to enroll 1,400 participants.