Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation

Early Feasibility Study (EFS) of the 'Pivot Extend' for the Treatment of Tricuspid Regurgitation, Including High-Risk Patients (SPACER Study, Australia)

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

Inclusion Criteria:

• Has voluntarily decided to participate in this clinical trial and has provided written informed consent
• Adults aged 18 years or older at the time of informed consent
• Has symptoms of TR corresponding to at least NYHA Class II, despite receiving optimal medical therapy for at least 30 days prior to screening
• Meets the criteria at least severe (3+) on the TR grade classification table on echocardiography performed at the screening visit
• Deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist and one cardiac surgeon
• Is able to understand and follow the investigator's instructions and is able to participate for the entire duration of the study

Exclusion Criteria:

• Has blood clots, emboli, masses, or growths in the vascular system of the heart or lungs on an echocardiogram and cardiac CT scan performed at the screening visit
• Uncorrected blood clotting disorders based on hematology tests performed at the screening visit
• Unable to use anticoagulant agents (NOAC ex.Xarelto)
• A history of major bleeding (excluding minor bleeding such as nosebleed that can be hemostasized) treated with anticoagulants at any time prior to participation in this clinical trial
• Severe anemia (hemoglobin less than or equal to 80g/L)
• Has an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker
• Has anatomy that, in the opinion of the investigator, is not suitable for implantation of an investigational medical device based on echocardiogram and cardiac CT scan performed at the screening visit
• Requires surgery or interventional procedures (coronary artery bypass graft (CABG) or surgery for atrial septal defect (ASD)) based on an echocardiogram performed at the screening visit
• Platelet count of 50 x 10^9 per litre of blood or less based on hematology tests performed at the screening visit
• Pulmonary arterial hypertension, defined as pulmonary artery systolic pressure greater than 70mmHg on cardiac catheterization performed at the screening visit, or a pulmonary vascular resistance greater than 3 Wood Units on right heart catheterization
• Left ventricular ejection fraction (LVEF) of less than 20% on echocardiogram performed at the screening visit
• Active gastrointestinal bleeding or a digestive procedure within 90 days prior to screening for this study, and/or those with the potential for gastrointestinal bleeding in the opinion of the investigator
• History of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to screening for this clinical trial
• History of myocardial infarction (MI) within 30 days prior to screening for this study
• Active endocarditis requiring antibiotic treatment
• Malignancies or end-stage renal failure requiring hemodialysis and other chronic conditions with a life expectancy of less than one year
• Moderate or severe aortic, pulmonary artery, or mitral stenosis on echocardiogram performed at the screening visit
• Severe or greater mitral valve regurgitation or severe aortic valve regurgitation as determined by echocardiographic grading criteria at the screening visit
• Calcification of the tricuspid valve leaflets affecting the procedure on an echocardiogram performed at the screening visit
• Those who have participated in another clinical trial within 30 days prior to screening for this clinical trial
• Pregnant or breastfeeding, or planning to become pregnant during the clinical trial period
• Participants of childbearing potential who are not using a highly effective method of contraception
• Coexisting condition, which most likely limits the life expectancy to less than one year
• Preexisting pulmonary valve prosthesis or a right ventricle to pulmonary artery (RV-PA) conduit
• Any other clinical findings that, in the opinion of the investigator, are medically inappropriate for this clinical trial