Condition: Arrhythmias, Cardiac · Atrial Fibrillation · Heart Diseases · Sponsor: Starmed
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.
Eunji shin · +82-31-816-3546 · eunji.shin@starmed4u.com
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| Bucheon Sejong Hospital | Bucheon-si, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06358391