The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat Functional Tricuspid Regurgitation
The purpose of this clinical trial is as follows. To assess the safety of the investigational medical device Pivot Bridge in participants aged 18 years or older with massive or greater functinal tricuspid regurgitation (TR) who have received medical therapy (diuretics/pharmacological treatment) for at least one month. To evaluate clinical outcomes related to improvement of tricuspid regurgitation symptoms following implantation of the Pivot Bridge device, including procedure success and clinical success. This study is designed as a self-controlled case series without a separate control group. The participant's non-exposure period to the investigational medical device, consisting of prior medical therapy (Medical Treatment, MT), is defined as the control period. The study compares (1) a period of fixed-dose medical therapy maintained for up to one week prior to application of the investigational medical device, and (2) a period during which the investigational medical device is temporarily implanted (within 1 week) in conjunction with medical therapy (Pivot Bridge, PB). To quantitatively evaluate the efficacy of the investigational medical device in inducing improvement of tricuspid regurgitation, the following are assessed: 1. improvement in regurgitation severity from baseline to Day 4-7 during fixed-dose medical therapy (ΔMT), and 2. improvement from pre-application to the time of device removal following additional application of the Pivot Bridge (ΔPB).
⁃ Subjects who meet all of the following criteria will be enrolled
• Adults aged 18 years or older at the time of screening
• Subjects who have received appropriate medical treatment (diuretics/medical therapy) for tricuspid regurgitation for at least 1 month prior to participation in this clinical trial
• Subjects who, at the screening visit, are assessed by transthoracic echocardiography (TTE) to have functional tricuspid regurgitation severity of Massive (4+) or greater, as defined by Tricuspid Valve Academic Research Consortium classification, and who have clinical symptoms corresponding to New York Heart Association (NYHA) functional class II or higher
• Subjects who, at the screening visit, are found on TTE or cardiac computed tomography (CT) to have a right ventricle (RV) larger than the left ventricle (LV)
• Subjects who, at the screening visit, are found on cardiac CT to have an annular diameter of 40 mm or greater
• Subjects for whom the Heart Team, consisting of at least one cardiologist (specialist in cardiology) and at least one cardiac surgeon, has determined that surgical treatment for isolated Tricuspid Regurgitation is required
• Subjects who voluntarily decide to participate in this clinical trial and provide written informed consent on the subject consent form
• Subjects who are able to understand and comply with the investigator's instructions and participate throughout the entire clinical trial period