RecruitingNot ApplicableNCT07385625

Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation

The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat Functional Tricuspid Regurgitation

Sponsor

Tau-MEDICAL Co., Ltd.

Enrollment

20 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Tricuspid Regurgitation Functional

Summary

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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

Exclusion Criteria22

Subjects who meet any of the following criteria will be excluded
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
Subjects who, prior to participation in this clinical trial, have had devices such as an implantable cardioverter defibrillator (ICD) or a pacemaker implanted
Subjects who, based on echocardiography and cardiac CT performed at the screening visit, are judged by the investigator to have anatomical structures unsuitable for implantation of the investigational medical device
Subjects who, based on clinical laboratory tests performed at the screening visit, have a platelet count of ≤80,000/µL
Subjects who, based on echocardiography performed at the screening visit, have pulmonary hypertension with TR Vmax ≥3.5 m/s
Subjects who, based on echocardiography performed at the screening visit, have left ventricular ejection fraction (LVEF) \<50%
Subjects who, within 3 months prior to participation in this clinical trial, have had active gastrointestinal bleeding or have undergone gastrointestinal procedures (subjects with a risk of gastrointestinal bleeding)
Subjects who, within 30 days prior to participation in this clinical trial, have a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA)
Subjects who, within 30 days prior to participation in this clinical trial, have a history of myocardial infarction (MI)
Subjects with active infective endocarditis requiring antibiotic therapy
Subjects with severe terminal illnesses (e.g., malignant tumors, end-stage pulmonary disease, end-stage liver disease, end-stage renal failure)
Subjects who, based on echocardiography performed at the screening visit, have moderate or severe aortic, pulmonary, or mitral stenosis
Subjects who, based on echocardiography performed at the screening visit, are found to have calcification of the tricuspid valve leaflets that would affect the procedure
Subjects who, based on echocardiography performed at the screening visit, are found to have masses, thrombi, or proliferative lesions in the right heart system, femoral vein, or inferior vena cava
Subjects who, within 30 days prior to participation in this clinical trial, have participated in another clinical trial
Pregnant or lactating women, and women planning to become pregnant during the study period
Women of childbearing potential who are not using medically acceptable methods of contraception
Subjects who, in addition to the above, are deemed by the investigator to have clinically significant findings that make them inappropriate for participation in this trial

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Interventions

DEVICEPivot Bridge

The 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.