Pivot Extend device to treat severe tricuspid regurgitation
Early Feasibility Study (EFS) of the 'Pivot Extend' for the Treatment of Tricuspid Regurgitation, Including High-Risk Patients (SPACER Study, Australia)
This trial will try the Pivot Extend device in adults with severe, symptomatic tricuspid regurgitation to see if it safely reduces valve leakage and improves symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tau-MEDICAL Co., Ltd. Industry-sponsored |
| Locations | 1 site (Macquarie Park, New South Wales) |
| Trial ID | NCT07172477 on ClinicalTrials.gov |
What this trial studies
This early-phase interventional trial tests a percutaneously implanted device called Pivot Extend designed to reduce tricuspid valve regurgitation by acting as a spacer/implant within the tricuspid annulus. Eligible adults have at least severe (3+) TR and symptoms despite optimal medical therapy and are judged suitable for a catheter-based procedure by a multidisciplinary Heart Team. Primary goals are to measure device and procedural safety and success, plus clinical outcomes such as symptom class and valve regurgitation after implantation. Procedures and follow-up are conducted at a site in Macquarie Park, NSW, with imaging and clinical exams used to track results.
Who should consider this trial
Good fit: Adults aged 18 or older with symptomatic, at least severe (3+) tricuspid regurgitation despite optimal medical therapy who are deemed appropriate for percutaneous valve intervention by a Heart Team.
Not a fit: Patients with intracardiac or pulmonary vascular clots/masses, uncorrected bleeding disorders, or those not judged suitable for a percutaneous approach are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, Pivot Extend could provide a less invasive option to reduce tricuspid regurgitation and improve symptoms for patients at high risk from open-heart surgery.
How similar studies have performed: Transcatheter spacer and repair approaches for tricuspid regurgitation have produced promising early results in other programs, but the Pivot Extend device represents a newer approach that requires additional data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Macquarie Park, New South Wales
- Macquarie University — Macquarie Park, New South Wales, Australia (Recruiting)
Study contacts
- Study coordinator: Alex (Jongyoon) Park
- Email: jypark@tau-medical.com
- Phone: +82-(51)515-8783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.