NCT06990230

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: First Affiliated Hospital of Ningbo University · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and efficacy of radiofrequency transseptal puncture system and its auxiliary radiofrequency puncture device in atrial septum. Evaluation indicators: Success rate of atrial septum; The time required to successfully complete the atrial septum; Rate of failed atrial septal puncture crossing to the contralateral group; Performance evaluation of an RF transseptal puncture system; The incidence of complications related to atrial septal puncture; Rates of adverse events; Rates of serious adverse events.

Conditions

• Evaluation of the Radiofrequency Transseptal Puncture System
• Atrial Septum Puncture

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-27
• Primary completion: 2024-07-17
• Completion: 2024-09-30
• First posted: 2025-05-25
• Last updated: 2025-05-25

Locations

1 site across 1 country: China