Actively Recruiting
Early Feasibility Study of the Pivot Extend Device for Treating Severe Tricuspid Regurgitation Including High-Risk Patients
Led by Tau Medical Australia Pty Ltd · Updated on 2025-12-09
10
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
T
Tau Medical Australia Pty Ltd
Lead Sponsor
T
Tau-MEDICAL Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the investigational "Pivot Extend" device in adults aged 18 years or older who have severe and symptomatic tricuspid regurgitation (TR) and are suitable for a less invasive valve procedure. The study focuses on participants who face high risks with traditional heart valve surgery, such as elderly patients or those with other health issues. The device is being assessed to improve symptoms by helping the valve close more tightly. The Pivot Extend device is inserted through a small incision in the leg vein and guided to the heart using a catheter. It is designed to sit in the gap where the valve does not close properly, helping reduce blood leaking back through the valve. This study includes implantation of the device, followed by evaluations at various time points up to one year after the procedure to monitor device and procedural success as well as clinical outcomes. Participants will undergo screening including heart imaging and blood tests before device implantation. After the procedure, they will be monitored closely for safety and effectiveness at 30 days, 180 days, and 365 days. Researchers will assess the success of the device placement, improvements in symptoms, and overall heart function. The total duration of participation includes follow-up visits across one year to ensure thorough observation of outcomes and safety.
CONDITIONS
Brief Title
Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has voluntarily decided to participate and provided written informed consent
- Adults aged 18 years or older at consent
- Symptoms of tricuspid regurgitation at least NYHA Class II despite optimal medical therapy for at least 30 days
- Severe (3+) tricuspid regurgitation on echocardiography at screening
- Suitable for percutaneous valve intervention as determined by a Heart Team including a cardiologist and cardiac surgeon
- Able to understand instructions and participate for the entire study duration
You will not qualify if you...
- Blood clots, emboli, masses, or growths in heart or lung vessels on heart imaging at screening
- Uncorrected blood clotting disorders
- Unable to use anticoagulant medications
- History of major bleeding treated with anticoagulants prior to participation
- Severe anemia (hemoglobin ≤ 80g/L)
- Implanted devices such as pacemaker or defibrillator
- Unsuitable anatomy for device implantation
- Need for other heart surgeries based on imaging
- Low platelet count (≤ 50 x 10^9/L)
- Pulmonary arterial hypertension with high pressure or resistance
- Left ventricular ejection fraction less than 20%
- Recent active gastrointestinal bleeding or procedures
- Recent stroke or transient ischemic attacks
- Recent heart attack
- Active endocarditis requiring antibiotics
- Life expectancy less than one year due to malignancies or other chronic conditions
- Moderate or severe stenosis of aortic, pulmonary, or mitral valves
- Severe mitral or aortic valve regurgitation
- Calcification of tricuspid valve leaflets affecting procedure
- Participation in another clinical trial within 30 days
- Pregnant, breastfeeding, or planning pregnancy during trial
- Childbearing potential without effective contraception
- Preexisting pulmonary valve prosthesis or right ventricle to pulmonary artery conduit
- Any other medical condition making participation inappropriate as judged by investigator
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 - Single procedure day
Participants have the Pivot Extend device implanted through a small incision in the femoral vein to treat severe tricuspid regurgitation.
1 implantation procedure visit (in-person)
Duration - Up to 365 days post device implantation
Participants are monitored for safety and clinical outcomes after device implantation.
Visits at 30 days, 180 days, and 365 days post device implantation (in-person)
Trial Site Locations
Total: 1 location
1
Macquarie University
Macquarie Park, New South Wales, Australia, 2109
Actively Recruiting
Research Team
A
Alex (Jongyoon) Park
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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