NCT06358391

To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.

A Prospective, Multi-center, Randomized, Single-blind, Non-inferiority Confirmatory Study Designed to Compare and Assess Efficacy and Safety Between "TS-RF System Consisting of a Electrosurgical System, General-purpose (TS-RF Generator) and a Electrosurgical System Electrode, Hand-controlled, General-purpose, Single-use (TS-RF Needle)" and "Needle, Puncture, Single-use (BRK Transseptal Needle)", Both of Which Are Used for the Transseptal Puncture Performed to Enable Left Atrial Access for the Treatment of Symptomatic Arrhythmia and Mitral Stenosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Starmed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis and then to demonstrate that the study device is non-inferior to the control device.

Detailed description

The efficacy and safety of radiofrequency (RF) needles in transseptal puncture have been well established through several comparative clinical studies. In foreign countries, RF needles have already been used for transseptal puncture for more than 20 years since the FDA approval of the first RF Needle. However, in Korea, despite the fact that it has been approximately 30 years since the initiation of radiofrequency catheter ablation (RFCA) for the treatment of arrhythmia, only the conventional mechanical needles have still been available after authorization for transseptal puncture that is the key for the treatment of cardiac disorders such as mitral stenosis as well as a part of RFCA for the treatment of arrhythmia. Therefore, this study aims to compare and assess efficacy and safety between the study device "TS-RF system consisting of a electrosurgical system, general-purpose (TS-RF Generator) and a electrosurgical system electrode, hand-controlled, general-purpose, single-use (TS-RF Needle)" and the control device "needle, puncture, single-use (BRK Transseptal needle)", both of which are used for the transseptal puncture performed to enable left atrial access for the treatment of symptomatic arrhythmia and mitral stenosis, and then to demonstrate that the study device is non-inferior to the control device.

Conditions

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Heart Diseases

Interventions

Type	Name	Description
DEVICE	TS-RF Transseptal Needle	Apply radiofrequency energy to the electrode tip via the TS-RF Generator and puncture the atrial septum
DEVICE	BRK Transseptal Needle	Cross and puncture the atrial septum with the BRK Transseptal Needle

Timeline

• Start date: 2024-08-21
• Primary completion: 2024-12-31
• Completion: 2025-03-31
• First posted: 2024-04-10
• Last updated: 2024-08-27

Locations

1 site across 1 country: South Korea