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 range18 Years

SexALL

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

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