Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07172477




Registration number
NCT07172477
Ethics application status
Date submitted
19/08/2025
Date registered
15/09/2025
Date last updated
15/09/2025

Titles & IDs
Public title
Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation
Scientific title
Early Feasibility Study (EFS) of the 'Pivot Extend' for the Treatment of Tricuspid Regurgitation, Including High-Risk Patients (SPACER Study, Australia)
Secondary ID [1] 0 0
TCP-EFS-12-AU
Universal Trial Number (UTN)
Trial acronym
SPACER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tricuspid Regurgitation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Pivot Extend

Experimental: Pivot Extend device - Patients aged 18 years or older with severe and symptomatic tricuspid regurgitation


Treatment: Devices: Pivot Extend
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety of the implantation of the "Pivot Extend" device
Timepoint [1] 0 0
30 days post device implantation
Secondary outcome [1] 0 0
To evaluate the Pivot Extend device success
Timepoint [1] 0 0
During implantation procedure
Secondary outcome [2] 0 0
To evaluate the procedural success (1)
Timepoint [2] 0 0
30 days, 180 days and 365 days post device implantation
Secondary outcome [3] 0 0
To evaluate the procedural success (2)
Timepoint [3] 0 0
30 days, 180 days and 365 days post device implantation
Secondary outcome [4] 0 0
To evaluate the procedural success (3)
Timepoint [4] 0 0
180 and 365 days after device implantation
Secondary outcome [5] 0 0
To evaluate the procedural success (4)
Timepoint [5] 0 0
30 days, 180 days and 365 days post device implantation
Secondary outcome [6] 0 0
To evaluate the clinical outcomes (1)
Timepoint [6] 0 0
180 days and 365 days post device implantation
Secondary outcome [7] 0 0
To evaluate the clinical outcomes (2)
Timepoint [7] 0 0
180 days and 365 days post device implantation
Secondary outcome [8] 0 0
To evaluate the clinical outcomes (3)
Timepoint [8] 0 0
30 days, 180 days and 365 days post device implantation
Secondary outcome [9] 0 0
To evaluate clinical outcomes (4)
Timepoint [9] 0 0
30 days, 180 days and 365 days post device implantation
Secondary outcome [10] 0 0
To evaluate clinical outcomes (5)
Timepoint [10] 0 0
30 days, 180 days and 365 days post device implantation
Secondary outcome [11] 0 0
To evaluate clinical outcomes (6)
Timepoint [11] 0 0
30 days, 180 days and 365 days post device implantation
Secondary outcome [12] 0 0
To evaluate clinical outcome measures (7)
Timepoint [12] 0 0
30 days, 180 days and 365 days post device implantation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tau Medical Australia Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Tau-MEDICAL Co., Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
June-Hong Kim, PhD
Address 0 0
Tau-MEDICAL Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alex (Jongyoon) Park
Address 0 0
Country 0 0
Phone 0 0
+82-(51)515-8783
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07172477