RecruitingNot ApplicableNCT06358391

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

Sponsor

Starmed

Enrollment

70 participants

Start Date

Aug 21, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of needles used to access the left side of the heart during heart procedures — a standard needle (BRK) versus a radiofrequency-powered needle (TS-RF). These needles are used in procedures to treat abnormal heart rhythms like atrial fibrillation. The study is measuring which tool is safer and more effective. **You may be eligible if...** - You are 18 or older - You have been diagnosed with atrial fibrillation, atrial flutter, or another heart rhythm disorder that requires a left-heart catheter procedure - You are scheduled for an ablation or other procedure that requires crossing from the right to the left side of the heart through the septum (the wall between the chambers) **You may NOT be eligible if...** - You have had a prior procedure on the heart's septal wall that has left scar tissue - You have a blood clot inside the heart - You have severe heart valve disease or other anatomical issues that prevent this type of procedure - You are pregnant - You are unable to take blood-thinning medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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