Actively 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.
Led by Starmed · Updated on 2026-04-24
70
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
Sponsors
S
Starmed
Lead Sponsor
H
Helptrial
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with symptomatic arrhythmia including atrial fibrillation (paroxysmal, persistent, long-standing persistent, permanent), paroxysmal supraventricular tachycardia, ectopic atrial rhythm tachycardia, ventricular tachycardia, or arrhythmia requiring left atrial access
- Diagnosed with symptomatic mitral stenosis requiring percutaneous mitral valvuloplasty through left atrial access
- Able to understand and voluntarily sign the informed consent form
You will not qualify if you...
- Significant congenital heart defects such as atrial septal defect or pulmonary vein abnormalities (excluding patent foramen ovale)
- Thrombus in the left atrium
- Atrial fibrillation due to reversible causes like hyperthyroidism or thoracic surgery
- Known or suspected left atrial myxoma
- Unstable angina
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
- Liver disease including active hepatitis or kidney disease
- Cerebral ischemic event (stroke or TIA) within six months before consent
- Malignant tumors or hematological diseases or life expectancy less than one year
- Participation in another clinical trial that may interfere with this study
- Unwilling or unable to comply fully with study procedures and follow-up
- Pregnant, planning pregnancy, or lactating women
- Judged ineligible for the study by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bucheon Sejong Hospital
Bucheon-si, South Korea
Actively Recruiting
Research Team
E
Eunji shin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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