First-in-human study of a leadless pacemaker system for left bundle branch area pacing
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023884%3A_____%2F25%3A00010237" target="_blank" >RIV/00023884:_____/25:00010237 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11110/25:10511084
Result on the web
<a href="https://pubmed.ncbi.nlm.nih.gov/40300740/" target="_blank" >https://pubmed.ncbi.nlm.nih.gov/40300740/</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.hrthm.2025.04.030" target="_blank" >10.1016/j.hrthm.2025.04.030</a>
Alternative languages
Result language
angličtina
Original language name
First-in-human study of a leadless pacemaker system for left bundle branch area pacing
Original language description
BACKGROUND: Leadless pacemakers (LPs) are limited by the current inability to perform left bundle branch area pacing (LBBAP). OBJECTIVE: The purpose of this first-in-human acute feasibility study was to evaluate the safety and performance of a novel helix-based LP with an extended electrode for LBBAP (LPCSP). METHODS: After obtaining informed consent, the LPCSP (Aveir CSP LP) was temporarily deployed in patients with indications for LP implantation. The LPCSP was introduced from the right internal jugular (IJ) vein and temporarily implanted deep into the interventricular septum (IVS) under fluoroscopic and intracardiac echocardiographic guidance. The primary safety endpoint was freedom from serious device adverse events (SADEs) within 1 month of the implant procedure. The primary performance endpoints were intraprocedural electrical parameters, including pacing threshold, impedance, and sensed R-wave amplitude. The LPCSP then was removed, and a conventional LP was implanted in the right ventricle using the same IJ access. RESULTS: Among 14 enrolled patients (age 69.4 ± 9.9 years, 71% male), the LPCSP was successfully implanted into the IVS in 10 patients. Pacing threshold (1.2 ± 0.6 V at 0.4 ms), R-wave amplitude (10.2 ± 4.1 mV), and impedance (373 ± 56 Ω) were acceptable. LBBAP capture was observed in 5 patients, segmented into direct capture of the left bundle branch (n = 1) and left ventricular septal pacing (n = 4). Deep septal pacing was observed in 3 additional patients. Freedom from SADEs within 1 month of the implant procedure was 85.7%. CONCLUSION: This first-in-human study demonstrated acute successful implantation of the LPCSP with clinically acceptable intraprocedural electrical performance and safety.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30201 - Cardiac and Cardiovascular systems
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2025
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Heart Rhythm
ISSN
1547-5271
e-ISSN
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Volume of the periodical
22
Issue of the periodical within the volume
8
Country of publishing house
US - UNITED STATES
Number of pages
8
Pages from-to
2010-2017
UT code for WoS article
001544833200028
EID of the result in the Scopus database
2-s2.0-105007024256