Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06358391
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-01
Brief Title:
To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access
Sponsor:
Starmed
Organization:
Starmed
Study Overview
Official Title:
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
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None