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

Recruiting N/A Interventional Study
Arrhythmias, Cardiac Atrial Fibrillation Heart Diseases
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Starmed · Industry
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About This Trial
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 tran…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. ≥ 18 years of age 2. Diagnosed with one of the following cardiac disorders as shown in the medical record: \[Symptomatic arrhythmia\] * "Atrial fibrillation" diagnostics (including paroxysmal, persistent, long-standing persistent and permanent atrial fibrillation) …
Contacts

Eunji shin

+82-31-816-3546

eunji.shin@starmed4u.com

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