To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles … (NCT06358391) | Clinical Trial Compass
RecruitingNot Applicable
To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access.
South Korea70 participantsStarted 2024-08-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥ 18 years of age
✓. Diagnosed with one of the following cardiac disorders as shown in the medical record:
✓"Mitral Stenosis requiring percutaneous mitral valvuloplasty through left atrial access" diagnostics
✓. Understood this clinical study and voluntarily signed the informed consent form (ICF)1
Exclusion criteria
✕. Patients with significant congenital heart defects, such as atrial septal defect or pulmonary vein (PV) abnormalities (excluding patent foramen ovale (PFO)).
✕. Thrombus in the left atrium
✕. Atrial fibrillation to reversible causes (e.g. hyperthyroidism, thoracic surgery)