Actively Recruiting
Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation
Led by Tau-MEDICAL Co., Ltd. · Updated on 2026-02-04
20
Participants Needed
4
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at the time of screening
- Received appropriate medical treatment (diuretics/medical therapy) for tricuspid regurgitation for at least 1 month prior to participation
- Functional tricuspid regurgitation severity of Massive (4+) or greater by transthoracic echocardiography with New York Heart Association functional class II or higher symptoms
- Right ventricle larger than left ventricle on echocardiography or cardiac computed tomography
- Annular diameter of 40 mm or greater on cardiac computed tomography
- Determined by a Heart Team (cardiologist and cardiac surgeon) to require surgical treatment for isolated tricuspid regurgitation
- Voluntarily agree to participate and provide written informed consent
- Able to understand and comply with study instructions throughout the trial period
You will not qualify if you...
- Presence of thrombus or embolic material on echocardiography or cardiac computed tomography at screening
- Uncorrected coagulation disorders based on clinical laboratory tests at screening
- Unable to use anticoagulant agents
- History of major bleeding due to anticoagulants requiring treatment or severe anemia needing hospitalization
- Prior implantation of devices such as implantable cardioverter defibrillator or pacemaker
- Anatomical structures unsuitable for device implantation judged by investigator
- Platelet count less than or equal to 80,000/µL based on laboratory tests
- Pulmonary hypertension with tricuspid regurgitation Vmax greater than or equal to 3.5 m/s on echocardiography
- Left ventricular ejection fraction less than 50% on echocardiography
- Active gastrointestinal bleeding or gastrointestinal procedures within 3 months prior to participation
- History of cerebrovascular accident or transient ischemic attack within 30 days
- History of myocardial infarction within 30 days
- Active infective endocarditis requiring antibiotic therapy
- Severe terminal illnesses such as malignant tumors or end-stage organ diseases
- Moderate or severe aortic, pulmonary, or mitral valve stenosis on echocardiography
- Calcification of tricuspid valve leaflets affecting procedure on echocardiography
- Masses, thrombi, or proliferative lesions in the right heart system, femoral vein, or inferior vena cava
- Participation in another clinical trial within 30 days prior to participation
- Pregnant or lactating women, or planning pregnancy during study
- Women of childbearing potential not using medically acceptable contraception
- Other clinically significant findings deemed inappropriate for participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, South Korea, 42601
Actively Recruiting
2
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50602
Actively Recruiting
3
Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-gu, South Korea, 03722
Actively Recruiting
4
Asan Medical Center
Seoul, Songpa-gu, South Korea, 05505
Actively Recruiting
Research Team
J
June-Hong Kim, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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