Beating a New Path: Groundbreaking Homegrown Cardiac Research Team Pioneers Clinical Trial for Innovative Arrhythmia Treatment Device
Arrhythmia: A Growing Concern in South Korea
What is Arrhythmia?
Arrhythmia is a disease that occurs when the electrical signals of the heart are not transmitted normally, resulting in irregular heartbeats. This condition can be caused by various factors, including structural abnormalities of the heart, genetic factors, stress, smoking, drinking, drugs, high blood pressure, diabetes, and obesity.
Symptoms and Complications
Major symptoms of arrhythmia include palpitations, dizziness, shortness of breath, chest pain, fainting, and fatigue. In severe cases, it can cause serious complications such as heart attack or stroke, making caution essential.
The Rise of Arrhythmia in South Korea
Over the past 10 years, the hospitalization rate due to arrhythmia has increased 4.2 times, and the cost of treatment has also increased approximately 5.7 times. From 2013 to 2022, the prevalence of arrhythmia in Korean adults has doubled from 1.1% to 2.2%. Atrial fibrillation, a type of arrhythmia, is reported to have more than 37 million patients worldwide in 2017.
Clinical Trial for Arrhythmia Treatment
A multi-institutional prospective randomized confirmatory clinical trial is currently being conducted by medical staff from Bucheon Sejong Hospital, Korea University Anam Hospital, and Sinchon Severance Hospital. This clinical trial aims to evaluate the efficacy and safety of transatrial septal puncture for the treatment of arrhythmia and mitral stenosis.
The Clinical Trial’s Objective
“This clinical study will evaluate the effectiveness and safety of improved transatrial septal puncture for the treatment of symptomatic arrhythmias and mitral valve stenosis, contributing to providing more effective and safer treatment methods for arrhythmia patients in the future,” said Sang-Won Park, director of Bucheon Sejong Hospital.
The Medical Device Used in the Clinical Trial
The medical device product used in this clinical trial, TS-RF, is a product developed by Starmed Co., Ltd., a domestic high-frequency medical device manufacturer. This product is currently undergoing domestic clinical trials and is preparing for approval by the Ministry of Food and Drug Safety in Korea and launching in global markets such as Japan and the United States.
Image 1: [Image description: From the left in the picture, Director Sangwon Park of Bucheon Sejong Hospital and Korea University Anam Hospital]
Image 2: [Image description: TS-RF medical device products used in clinical trials]
Source: Starmed Inc.