Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F21%3A00009184" target="_blank" >RIV/00023884:_____/21:00009184 - isvavai.cz</a>
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S2405500X21009221?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S2405500X21009221?via%3Dihub</a>
DOI - Digital Object Identifier
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Result language
angličtina
Original language name
Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial
Original language description
The first leadless cardiac pacemaker (LP; Nanostim, St. Jude Medical) was introduced in 2013 in international clinical trials (including LEADLESS II–Phase 1) but it was removed from the market because of premature battery depletion. The redesigned LP (Aveir, Abbott) has key design improvements, including the use of standard transvenous pacemaker battery chemistry (lithium carbon-monofluoride) with a 12% longer battery life (1.1 years longer, to 10.4 years), an altered form factor (10% shorter, 1.5-F wider, to 19.5-F), a modified docking button (enabling retrievability), a modified delivery system with an ergonomic design, and a new application-specific integrated circuit (ASIC) chip designed to provide an expandable platform (to later support a dual-chamber pacing system once approved). Here we present the first-in-human experience with this novel, newly designed LP in the LEADLESS II–Phase 2 Investigational Device Exemption study.
Czech name
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Czech description
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Publication year
2021
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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