Actively Recruiting
Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation
Led by Tau Medical Australia Pty Ltd · Updated on 2025-12-09
10
Participants Needed
1
Research Sites
67 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
Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients or those with other medical conditions. The goal of this clinical investigation is * To assess the safety of the investigational device "Pivot Extend" in participants aged 18 years or over with severe and clinically symptomatic Tricuspid Regurgitation (TR) deemed suitable for percutaneous valve intervention * To evaluate device success, procedural success and clinical outcomes in improving TR symptoms following implantation of the "Pivot Extend" device
CONDITIONS
Official 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...
- Adults aged 18 years or older who have voluntarily agreed and provided written informed consent
- Symptoms of tricuspid regurgitation at least NYHA Class II despite optimal medical therapy for 30 days before screening
- Severe tricuspid regurgitation (grade 3+ or higher) confirmed by echocardiography at screening
- Deemed suitable for percutaneous valve intervention by a Heart Team including a cardiologist and cardiac surgeon
- Able to understand and follow study instructions and participate for the study duration
You will not qualify if you...
- Presence of blood clots, emboli, masses, or growths in the heart or lung vessels seen on echocardiogram or cardiac CT
- Uncorrected blood clotting disorders
- Unable to take anticoagulant medications such as NOACs
- History of major bleeding treated with anticoagulants
- Severe anemia (hemoglobin ≤ 80 g/L)
- Having an implanted device like a pacemaker or defibrillator
- Anatomy unsuitable for device implantation as judged by imaging
- Need for other heart surgeries or interventions based on echocardiogram
- Low platelet count (≤ 50 x 10^9/L)
- Pulmonary arterial hypertension with specified measurements
- Left ventricular ejection fraction less than 20%
- Active gastrointestinal bleeding or recent digestive procedures within 90 days
- Recent stroke or transient ischemic attack within 30 days
- Recent heart attack within 30 days
- Active endocarditis requiring antibiotics
- Malignancy, end-stage kidney failure requiring dialysis, or other conditions limiting life expectancy to less than one year
- Moderate to severe stenosis of aortic, pulmonary artery, 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 not using effective contraception if of childbearing potential
- Preexisting pulmonary valve prosthesis or right ventricle to pulmonary artery conduit
- Any other medical conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Macquarie University
Macquarie Park, New South Wales, Australia, 2109
Actively Recruiting
Research Team
A
Alex (Jongyoon) Park
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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