Actively Recruiting
The Study for Evaluation of Acute Phase Safety and Efficacy of 'Pivot Bridge' to Short-term Treat Functional Tricuspid Regurgitation
Led by Tau-MEDICAL Co., Ltd. · Updated on 2026-02-04
20
Participants Needed
4
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the safety and effectiveness of an investigational medical device called the "Pivot Bridge" in adults aged 18 years or older who have massive or greater functional tricuspid regurgitation and have been treated with medical therapy such as diuretics for at least one month. The study focuses on evaluating improvements in symptoms and clinical outcomes related to this heart valve condition by comparing periods before and after device implantation, without a separate control group. The investigational "Pivot Bridge" device is inserted through a small incision in the femoral vein and guided to the heart using a catheter. It is designed to help the valve close more tightly and reduce blood leaking backward. The study involves a self-controlled case series with two periods: a fixed-dose medical therapy period lasting up to one week before device placement, and a period where the device is temporarily implanted for up to one week alongside medical therapy. Participants will undergo assessments including echocardiography and cardiac computed tomography to measure tricuspid regurgitation severity and heart function at baseline, during medical therapy, and during device implantation. Clinical success and procedural success will be evaluated based on improvements in valve function and symptoms at multiple time points, including up to one month after device removal. The study includes safety monitoring and requires participants to comply with study procedures throughout the trial duration.
CONDITIONS
Brief 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 medical therapy (diuretics/pharmacological treatment) for tricuspid regurgitation for at least 1 month
- Functional tricuspid regurgitation severity of Massive (4+) or greater confirmed by echocardiography and clinical symptoms of NYHA class II or higher
- Right ventricle larger than left ventricle as shown by echocardiography or cardiac CT
- Tricuspid valve annular diameter of 40 mm or greater on cardiac CT
- Determined by a Heart Team of cardiologist and cardiac surgeon to require surgical treatment for isolated tricuspid regurgitation
- Able to understand, comply with study instructions, and provide written informed consent
You will not qualify if you...
- Presence of thrombus or embolic material on echocardiography or cardiac CT
- Uncorrected coagulation disorders
- Unable to use anticoagulant agents
- History of major bleeding due to anticoagulants requiring treatment or severe anemia needing hospitalization
- Implanted devices such as pacemaker or implantable cardioverter defibrillator (ICD)
- Anatomical structures unsuitable for device implantation based on imaging
- Platelet count less than or equal to 80,000/µL
- Pulmonary hypertension with tricuspid regurgitation Vmax ≥3.5 m/s
- Left ventricular ejection fraction less than 50%
- Active gastrointestinal bleeding or recent gastrointestinal procedures within 3 months
- History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 30 days
- History of myocardial infarction within 30 days
- Active infective endocarditis requiring antibiotics
- Severe terminal illnesses such as malignant tumors, end-stage pulmonary, liver, or renal disease
- Moderate or severe aortic, pulmonary, or mitral stenosis
- Calcification of tricuspid valve leaflets affecting procedure
- Masses, thrombi, or lesions in right heart, femoral vein, or inferior vena cava
- Participation in another clinical trial within 30 days
- Pregnant or lactating women, or women planning pregnancy during study
- Women of childbearing potential not using medically accepted contraception
- Other clinically significant findings making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants have the Pivot Bridge device inserted through a small incision in the femoral vein to help reduce tricuspid regurgitation by improving valve function.
1 visit (in-person)
Duration - Up to 1 month after device removal
Participants are monitored for clinical and anatomical improvement of tricuspid regurgitation following device implantation, including assessments up to 1 month after device removal.
Approximately 3 visits (in-person) over 1 month
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here