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Study identifier: NCT06358391 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Arrhythmias, Cardiac · Atrial Fibrillation · Heart Diseases  ·  Sponsor: Starmed

PhaseNA
Planned participants70
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Eunji shin  ·  +82-31-816-3546  ·  eunji.shin@starmed4u.com

Always discuss trial participation with your own doctor first.

Locations (1)

Bucheon Sejong HospitalBucheon-si, South KoreaRecruiting

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Source record: clinicaltrials.gov/study/NCT06358391