All

What are you looking for?

All
Projects
Results
Organizations

Quick search

  • Projects supported by TA ČR
  • Excellent projects
  • Projects with the highest public support
  • Current projects

Smart search

  • That is how I find a specific +word
  • That is how I leave the -word out of the results
  • “That is how I can find the whole phrase”

Clinical evaluation of a small implantable cardiac monitor with a long sensing vector

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00098892%3A_____%2F19%3AN0000145" target="_blank" >RIV/00098892:_____/19:N0000145 - isvavai.cz</a>

  • Result on the web

    <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6851891/" target="_blank" >https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6851891/</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1111/pace.13728" target="_blank" >10.1111/pace.13728</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    Clinical evaluation of a small implantable cardiac monitor with a long sensing vector

  • Original language description

    Introduction: We conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance. Methods: The BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single-arm, multicenter prospective trial. Patients were followed for 3 months, and 48-h Holter recordings were used to evaluate the arrhythmia detection performance. Results: One patient withdrew consent and in one patient, the implantation failed. Two study device-related serious adverse events were reported, satisfying the primary safety hypothesis. Implantations took 7.4 ± 4.4 min from skin cut to suture. At 1 week, the R-wave amplitude was 0.75 ± 0.53 mV. In the 82 patients with completed Holter recordings, all patients with arrhythmias were correctly identified. False positive detections of arrhythmia were mostly irregular rhythms wrongly detected as atrial fibrillation (episode-based positive predictive value 72.5%). Daily Home Monitoring transmission was 94.9% successful. Conclusion: Safety and efficacy of the new device has been demonstrated. The detected R-wave amplitudes are large, leading to a low level of inappropriate detections due to over- or undersensing.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30201 - Cardiac and Cardiovascular systems

Result continuities

  • Project

  • Continuities

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Others

  • Publication year

    2019

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY

  • ISSN

    0147-8389

  • e-ISSN

    1540-8159

  • Volume of the periodical

    42

  • Issue of the periodical within the volume

    7

  • Country of publishing house

    US - UNITED STATES

  • Number of pages

    9

  • Pages from-to

    1038-1046

  • UT code for WoS article

    000474649700036

  • EID of the result in the Scopus database

    2-s2.0-85067606706