Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul

NACompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

May 27, 2024

Primary Completion Date

July 17, 2024

Study Completion Date

September 30, 2024

Conditions
Evaluation of the Radiofrequency Transseptal Puncture SystemAtrial Septum Puncture
Interventions
DEVICE

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"

Trial Locations (1)

215000

Heayoung Medical Technology (Suzhou) Co., Ltd, Suzhou

All Listed Sponsors
lead

First Affiliated Hospital of Ningbo University

NETWORK

NCT06990230 - Prospective, Multicenter, Randomized Controlled, Non-inferior Clinical Study to Evaluate the Safety and Efficacy of Radiofrequency Transseptal Puncture System in Atrial Septul | Biotech Hunter | Biotech Hunter