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).
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 in whom thrombus or embolic material is identified on echocardiography or cardiac computed tomography (CT) performed at the screening visit
Subjects who have uncorrected coagulation disorders as shown by clinical laboratory tests performed at the screening visit
Subjects who cannot use anticoagulant agents
Subjects who, prior to participation in this clinical trial, have experienced major bleeding due to the use of anticoagulants (minor bleeding such as controllable epistaxis does not apply) requiring treatment, or who have had severe anemia necessitating hospitalization
Single group
Pivot Bridge
DeviceThe investigational "Pivot Bridge" device will be inserted through a small incision in the femoral vein and guided to the heart using a catheter. The Pivot Bridge device is designed to sit in the space where the valve isn't closing, helping the flaps of the valve to close tightly and reducing the amount of blood leaking back through the valve.
Procedure Success Based on Improvement in Tricuspid Regurgitation Severity
Proportion of subjects achieving at least a 1-grade improvement in tricuspid regurgitation (TR grade) according to Tricuspid Valve Academic Research Consortium definitions
Clinical Success Based on Clinical Improvement
The number of participants who experienced at least 1 drop in their TR grade from Baseline
Clinical Success Based on Clinical Improvement(1)
Changes in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score (a measure of symptoms, physical limitation, social limitations and quality of life domains) from baseline. Participants will be asked to tick a box on a scale indicating how each domain affects their life (e.g. scales range from extremely limited to not at all limited, from every morning/night to never over the past 2 weeks, from completely dissatisfied to completely satisfied). The responses will be used to calculate an average score on a scale of 0 to 100. A higher score equates to better outcomes (i.e. fewer symptoms, better physical and social function, improved quality of life).
Clinical Success Based on Clinical Improvement(2)
Changes in eGFR (estimated glomerular filtration rate) from baseline
Clinical Success Based on Clinical Improvement(3)
Number of participants with at least 1 level of improvement in pitting edema from baseline
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