180
Participants
Start Date
May 27, 2024
Primary Completion Date
July 17, 2024
Study Completion Date
September 30, 2024
Radiofrequency Transseptal Puncture System and Auxiliary Device
"The intervention in this study stands out due to its specific focus on evaluating the safety and efficacy of a radiofrequency transseptal puncture system designed exclusively for use in the atrial septum, with the purpose of establishing a passage from the right atrium to the left atrium. This system incorporates an auxiliary radiofrequency puncture device, which serves as a crucial supportive component, enhancing the overall functionality and precision of the primary transseptal puncture system.~What further distinguishes this intervention from others is its utilization of radiofrequency energy to facilitate the transseptal puncture. Unlike traditional mechanical puncture methods, which can have a steep learning curve, potentially cause serious complications such as pericardial tamponade and cardiac rupture, and may be time-consuming and imprecise in predicting the puncture site, the radiofrequency puncture device provides a more controlled and predictable approach. The radiofrequenc"
Heayoung Medical Technology (Suzhou) Co., Ltd, Suzhou
First Affiliated Hospital of Ningbo University
NETWORK