Tricuspid RegurgitationSPACERNCT07172477
Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation
A study testing Pivot Extend in people with Tricuspid Regurgitation, run by Tau Medical Australia Pty Ltd at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- Pivot Extend
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Nov 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Macquarie University
Macquarie Park, New South Wales, 2109
Principal Investigator: Martin Ng, +61 (2) 9812 2956, martin.ng@sydney.edu.au
About this study
Official title: 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
- Conditions
- Tricuspid Regurgitation
- Being tested
- Pivot Extend
- Keywords
- Tricuspid Regurgitation, SPACER, Pivot Extend
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pivot ExtendDevice
The investigational "Pivot Extend" device will be inserted through a small incision in the femoral vein and guided to the heart using a catheter. The Pivot Extend device is designed to sit in the space where the valve isn't closing, helping the flaps of the valve to close tightly and reducing the amount of blood leaking back through the valve.
| Study group | Role | What they receive |
|---|---|---|
| Pivot Extend device | Experimental | Patients aged 18 years or older with severe and symptomatic tricuspid regurgitation Receives: Device: Pivot Extend |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of the implantation of the "Pivot Extend" device
Occurrence rate of major adverse cardiac events (MACE) (e.g. stroke, myocardial infarction, pulmonary embolism)
Measured: 30 days post device implantation
Secondary outcomes (12)
To evaluate the Pivot Extend device success
Rate of successful device placement at target location
Measured: During implantation procedure
To evaluate the procedural success (1)
The number of participants who experienced at least 1 drop in their TR grade from screening, based on echocardiographic assessment
Measured: 30 days, 180 days and 365 days post device implantation
To evaluate the procedural success (2)
Changes in echocardiogram (measurements and assessments of the heart's structure and function) as assessed by the central "Core Lab" reader
Measured: 30 days, 180 days and 365 days post device implantation
To evaluate the procedural success (3)
Occurrence rate of MACE associated with the device or procedure
Measured: 180 and 365 days after device implantation
To evaluate the procedural success (4)
Changes in Computed Tomography (CT) images (evaluating the size, shape and function of the tricuspid valve following Pivot Extend device insertion) as assessed by the central "Core Lab" reader.
Measured: 30 days, 180 days and 365 days post device implantation
To evaluate the clinical outcomes (1)
Changes in right ventricular volume from baseline, assessed by cardiac computed tomography (CT)
Measured: 180 days and 365 days post device implantation
To evaluate the clinical outcomes (2)
Changes in echocardiogram (measurements and assessments of the heart's structure and function) as assessed by the central "Core Lab" reader
Measured: 180 days and 365 days post device implantation
To evaluate the clinical outcomes (3)
Number of participants with improvement in New York Heart Association (NYHA) functional class (system to classify the severity of heart failure symptoms) from baseline
Measured: 30 days, 180 days and 365 days post device implantation
To evaluate clinical outcomes (4)
Measure in the changes of distance travelled during a 6 Minute Walk Test from baseline
Measured: 30 days, 180 days and 365 days post device implantation
To evaluate clinical outcomes (5)
Changes in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score (a measure of symptoms, physical limitation, social limitations and quality of life domains) from baseline. Participants will be asked to tick a box on a scale indicating how each domain affects their life (e.g. scales range from extremely limited to not at all limited, from every morning/night to never over the past 2 weeks, from completely dissatisfied to completely satisfied). The responses will be used to calculate an average score on a scale of 0 to 100. A higher score equates to better outcomes (i.e. fewer symptoms, better physical and social function, improved quality of life).
Measured: 30 days, 180 days and 365 days post device implantation
To evaluate clinical outcomes (6)
Number of participants with at least 1 level of improvement in pitting edema from baseline
Measured: 30 days, 180 days and 365 days post device implantation
To evaluate clinical outcome measures (7)
Changes in eGFR (estimated glomerular filtration rate) from baseline
Measured: 30 days, 180 days and 365 days post device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start11 Nov 2025
- Primary completionApr 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tau Medical Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tau-MEDICAL Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- June-Hong Kim, PhD, Study director, Tau-MEDICAL Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172477
- Sponsor's protocol ID
- TCP-EFS-12-AU
- Acronym
- SPACER
- Status last verified
- Dec 2025
- First submitted
- 19 Aug 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study (EFS) of the 'Pivot Extend' for the Treatment of Tricuspid Regurgitation, Including High-Risk Patients (SPACER Study, Australia)
- ClinicalTrials.gov ID
- NCT07172477
- Acronym / sponsor ID
- SPACER / TCP-EFS-12-AU
- Conditions
- Tricuspid Regurgitation
- Keywords
- Tricuspid Regurgitation, SPACER, Pivot Extend
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tau Medical Australia Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Tau-MEDICAL Co., Ltd.
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pivot Extend device | Experimental | Device: Pivot ExtendPatients aged 18 years or older with severe and symptomatic tricuspid regurgitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pivot ExtendThe investigational "Pivot Extend" device will be inserted through a small incision in the femoral vein and guided to the heart using a catheter. The Pivot Extend device is designed to sit in the space where the valve isn't closing, helping the flaps of the valve to close tightly and reducing the amount of blood leaking back through the valve. | Device | Pivot Extend device |
Primary outcome
To evaluate the safety of the implantation of the "Pivot Extend" device
Time frame: 30 days post device implantation
Occurrence rate of major adverse cardiac events (MACE) (e.g. stroke, myocardial infarction, pulmonary embolism)
12 secondary outcomes
To evaluate the Pivot Extend device success
Time frame: During implantation procedure
To evaluate the procedural success (1)
Time frame: 30 days, 180 days and 365 days post device implantation
To evaluate the procedural success (2)
Time frame: 30 days, 180 days and 365 days post device implantation
To evaluate the procedural success (3)
Time frame: 180 and 365 days after device implantation
To evaluate the procedural success (4)
Time frame: 30 days, 180 days and 365 days post device implantation
To evaluate the clinical outcomes (1)
Time frame: 180 days and 365 days post device implantation
To evaluate the clinical outcomes (2)
Time frame: 180 days and 365 days post device implantation
To evaluate the clinical outcomes (3)
Time frame: 30 days, 180 days and 365 days post device implantation
To evaluate clinical outcomes (4)
Time frame: 30 days, 180 days and 365 days post device implantation
To evaluate clinical outcomes (5)
Time frame: 30 days, 180 days and 365 days post device implantation
To evaluate clinical outcomes (6)
Time frame: 30 days, 180 days and 365 days post device implantation
To evaluate clinical outcome measures (7)
Time frame: 30 days, 180 days and 365 days post device implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
June-Hong Kim, PhD study director
Tau-MEDICAL Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pivot Extend in people with Tricuspid Regurgitation, run by Tau Medical Australia Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex (Jongyoon) Park (+82-(51)515-8783, jypark@tau-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of the implantation of the "Pivot Extend" device (time frame: 30 days post device implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.