Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial
Identifikátory výsledku
Kód výsledku v 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>
Výsledek na webu
<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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Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial
Popis výsledku v původním jazyce
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.
Název v anglickém jazyce
Primary Results on Safety and Efficacy From the LEADLESS II–Phase 2 Worldwide Clinical Trial
Popis výsledku anglicky
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.
Klasifikace
Druh
O - Ostatní výsledky
CEP obor
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OECD FORD obor
30201 - Cardiac and Cardiovascular systems
Návaznosti výsledku
Projekt
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Návaznosti
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Ostatní
Rok uplatnění
2021
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů