Actively Recruiting
Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment
Led by Tau-MEDICAL Co., Ltd. · Updated on 2025-04-11
7
Participants Needed
3
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial aims to evaluate the safety and demonstrate the efficacy of treatment to improve tricuspid regurgitation (TR) symptoms in patients with severe and clinically symptomatic TR through long-term implantation of an investigational medical device. 1. Determine the safety of long-term implantation of the investigational medical device "Pivot Extend" by monitoring for MACEs associated with the investigational medical device or procedure that may occur with long-term associated with the investigational medical device or procedure that may occur with long-term implantation. 2. Device success, procedural success, and clinical outcomes of long-term implantation of the investigational medical device "Pivot Extend" will be monitored.
CONDITIONS
Official Title
Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older at the time of screening
- Symptoms of tricuspid regurgitation despite medical therapy for at least 1 month
- Severe tricuspid regurgitation (grade 3+ or worse) confirmed by echocardiography at screening
- Clinical symptoms classified as New York Heart Association (NYHA) class 2 or worse
- Suitable for percutaneous valve intervention as determined by a Heart Team including cardiologist, cardiac surgeon, and anesthesiologist
- Voluntary participation with written informed consent
- Ability to understand instructions and participate for the entire study duration
You will not qualify if you...
- Presence of blood clots, emboli, masses, or growths in the heart or lung vessels on screening echocardiogram and cardiac CT
- Uncorrected blood clotting disorders based on blood tests at screening
- Inability to use anticoagulant medications like Xarelto
- History of major bleeding treated with anticoagulants prior to study
- Severe anemia (hemoglobin 10 g/dL or less) requiring hospitalization
- Existing implanted devices such as pacemaker or implantable cardioverter defibrillator
- Anatomy unsuitable for device implantation as judged by investigator
- Need for surgery or interventional procedures like coronary artery bypass graft or atrial septal defect repair
- Platelet count of 80,000/uL or less
- Pulmonary arterial hypertension with TR Vmax >3.5 m/s or pulmonary vascular resistance over 3 Wood Units
- Left ventricular ejection fraction below 50%
- Active gastrointestinal bleeding or digestive procedures within 3 months prior
- Recent cerebrovascular accident or transient ischemic attack within 30 days
- Recent myocardial infarction within 30 days
- Active endocarditis requiring antibiotics
- Life expectancy under one year due to malignancies, end-stage renal failure, or other chronic conditions
- Moderate or severe aortic, pulmonary artery, or mitral stenosis
- Moderate or worse mitral valve regurgitation or severe aortic valve regurgitation
- Calcification of tricuspid valve lobes affecting procedure
- Participation in another clinical trial within 30 days
- Pregnant or nursing women, or women planning pregnancy during the trial
- Women of childbearing potential not using medically accepted birth control
- Coexisting condition likely limiting life expectancy to less than one year
- Presence of pulmonary valve prosthesis or right ventricle to pulmonary artery conduit
- Other findings deemed medically inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, K'alak'i T'bilisi, Georgia, 0102
Actively Recruiting
2
Tbilisi Heart and Vascular Clinic
Tbilisi, K'alak'i T'bilisi, Georgia, 0159
Actively Recruiting
3
Tbilisi Heart Center
Tbilisi, K'alak'i T'bilisi, Georgia, 0186
Actively Recruiting
Research Team
M
Markus Reinthaler, MD, PhD
CONTACT
S
Seung-Whan Lee, 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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