Condition: Tricuspid Regurgitation Functional · Sponsor: Tau-MEDICAL Co., Ltd.
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).
This description comes directly from the study's public registry record.
June-Hong Kim, MD, PhD · +82-(51)515-8783 · junehongk@gmail.com
Always discuss trial participation with your own doctor first.
| Keimyung University Dongsan Hospital | Daegu, Dalseo-gu, South Korea | Recruiting |
| Pusan National University Yangsan Hospital | Yangsan, Gyeongsangnam-do, South Korea | Recruiting |
| Yonsei University Health System, Severance Hospital | Seoul, Seodaemun-gu, South Korea | Recruiting |
| Asan Medical Center | Seoul, Songpa-gu, South Korea | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07385625