Tricuspid Regurgitation (TR)NCT06877520
Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment
A study testing Pivot Extend Tricuspid Regurgitation Spacer Device in people with Tricuspid Regurgitation (TR), run by Tau-MEDICAL Co., Ltd. at 3 sites in Georgia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation (TR)
- What is being tested?
- Pivot Extend Tricuspid Regurgitation Spacer Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesGeorgia
- Study dates
- May 2025to Dec 2026
- 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
- Adults 18 years of age or older at the time of screening
- Those with symptoms despite medical therapy (OMT, diuretics/medications) for TR for at least 1 month at screening
- Those who meet the criteria of severe (3+) or worse on the TR grade classification table on echocardiography performed at the screening visit
- Those with clinical symptoms of New York Heart Association (NYHA) class 2 or worse
- Those deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist, one cardiac surgeon and one anesthesiologist.
- Those who have voluntarily decided to participate in this clinical trial and have provided written informed consent
- Those who can understand and follow the investigator's instructions and are able to participate for the entire duration of the study
Who cannot join
- Those with 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
- Those with uncorrected blood clotting disorders based on hemanalysis performed at the screening visit
- Those who are unable to use anticoagulant agents (NOAC ex.Xarelto)
- Those who have had major bleeding (not including minor bleeding, such as a nosebleed that can be hemostasized) treated with anticoagulants prior to participation in this clinical trial
- Those with severe anemia (hemoglobin ≦10g/dL) that requires hospitalization
- Those who have an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker prior to participation in this clinical trial
Show all 25Show fewer
- Those whose anatomy, 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
- Those who require 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
- Those with a platelet count of 80,000/uL or less based on hemanalysis performed at the screening visit
- Patients with pulmonary arterial hypertension with a TR Vmax greater than 3.5 m/s on echocardiography performed at the screening visit or a pulmonary vascular resistance of more than 3 Wood Units on right heart catheterization
- Those with a left ventricular ejection fraction (LVEF) of less than 50% on echocardiogram performed at the screening visit
- Those who have had active gastrointestinal bleeding or a digestive procedure within 3 months prior to participation in this study (those with the potential for gastrointestinal bleeding)
- Those with a history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to participation in this clinical trial
- Those with a history of myocardial infarction (MI) within 30 days prior to participation in this study
- Those with active endocarditis requiring antibiotic treatment
- Those with malignancies with end-stage renal failure requiring hemodialysis and other chronic conditions who have a life expectancy of less than one year
- Those with moderate or severe aortic, pulmonary artery, or mitral stenosis on echocardiogram performed at the screening visit
- Those with moderate or worse mitral valve regurgitation or severe aortic valve regurgitation on the echocardiogram performed at the screening visit
- Those with calcification of the tricuspid valve lobes affecting the procedure on an echocardiogram performed at the screening visit
- Those who have participated in another clinical trial within 30 days prior to participation in this clinical trial
- Pregnant or nursing women, or women planning to become pregnant during the clinical trial period
- Women of childbearing potential who are not using a medically accepted birth control method
- Those with a coexisting condition, which most likely limits the participant´s life expectancy to less than one year.
- Those with a preexisting pulmonary valve prosthesis or RV to PA conduit.
- Those with clinical findings other than the above that, in the opinion of the investigator, are medically inappropriate for this clinical trial
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Georgia3 sites, 3 recruiting
- Recruiting
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, K'alak'i T'bilisi, 0102
Irakli Gogorishvili, PhD, +995 243 33 43, info@hcore.ge
Irakli Gogorishvili, PhD
- Recruiting
Tbilisi Heart and Vascular Clinic
Tbilisi, K'alak'i T'bilisi, 0159
Tamaz Shaburishvili, PhD, +995 32 218 15 55, info@thvc.ge
Tamaz Shaburishvili, PhD
- Recruiting
Tbilisi Heart Center
Tbilisi, K'alak'i T'bilisi, 0186
Archil Chukhrukidze, PhD, +995 32 250 81 06, info@tbhc.ge
Archil Chukhrukidze, PhD
About this study
Official title: Early Feasibility Study (EFS) of the 'Pivot Extend' in Treatment for Tricuspid Regurgitation (SPACER Study)
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.
- 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.
- Device success, procedural success, and clinical outcomes of long-term implantation of the investigational medical device "Pivot Extend" will be monitored.
- Conditions
- Tricuspid Regurgitation (TR)
- Being tested
- Pivot Extend Tricuspid Regurgitation Spacer Device
- Keywords
- Pivot Extend, TauMedical
- 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 Extend Tricuspid Regurgitation Spacer DeviceDevice
The Pivot Extend Tricuspid Regurgitation Spacer Device is an investigational implant designed to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice and improving leaflet coaptation. The device is implanted via a transcatheter procedure under imaging guidance. Following implantation, participants will undergo post-procedural monitoring for at least 24 hours to ensure safety and device stability. The device is intended for long-term placement, with scheduled follow-up assessments at designated intervals over a 12-month period to evaluate its safety and efficacy. Device removal may be performed if adverse events occur or if deemed necessary by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Treatment to Improve TR Symptoms with Investigational Medical Device Implantation | Experimental | Participants assigned to this arm will receive an investigational medical device designed to improve symptoms of severe and clinically symptomatic tricuspid regurgitation (TR). Following device implantation, participants will be monitored in a specialized facility for at least 24 hours with real-time observation of vital signs. The device's safety and efficacy will be assessed over 12 months through scheduled visits, with clinical progress monitored throughout. Device removal may be performed if adverse events occur or if deemed necessary by the investigator. Receives: Device: Pivot Extend Tricuspid Regurgitation Spacer Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events(MACEs)
Occurrence Ratio of Major Adverse Cardiac Events (MACEs)
Measured: 1 month post-procedure
Secondary outcomes (9)
Device Success
The rate of the device successfully placed at target location
Measured: during procedure
Procedural Success(1)
Changes in TR Grade: The number of the participants who had at least 1 TR grade drop, confirmed through echocardiography
Measured: 1-month, 6-month, 12-month post-procedure
Procedural Success(2)
The occurrence rate of MACEs associated with the trial device or procedure
Measured: 1-month, 6-month, 12-month post-procedure
Clinical Outcomes(1)
Changes in anatomical structure: Changes in right ventricular volume from baseline confirmed through cardiac CT
Measured: 6-month, 12-month post-procedure
Clinical Outcomes(2)
Changes in NHYA Functional Class: The number of participants whose NYHA functional class improved compared to baseline
Measured: 1-month, 6-month, 12-month post-procedure
Clinical Outcomes(3)
Changes in Six Minute Walk Test (6MWT): Changes in distance compared to baseline
Measured: 1-month, 6-month, 12-month post-procedure
Clinical Outcomes(4)
Changes in KCCQ score: Changes in the assessed KCCQ score compared to baseline
Measured: 1-month, 6-month, 12-month post-procedure
Clinical Outcomes(5)
Changes in edema score: The number of participants who had at least 1 level improvement in edema score compared to baseline
Measured: 1-month, 6-month, 12-month post-procedure
Clinical Outcomes(6)
Changes in eGFR (estimated glomerular filtration rate): Changes in eGFR compared to baseline
Measured: 1-month, 6-month, 12-month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation (TR)Studies 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
- Model description
- Multi-center, open label, single arm, early feasibility study
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tau-MEDICAL Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877520
- Sponsor's protocol ID
- TCP-EFS-07-GE
- Status last verified
- Apr 2025
- First submitted
- 10 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study (EFS) of the 'Pivot Extend' in Treatment for Tricuspid Regurgitation (SPACER Study)
- ClinicalTrials.gov ID
- NCT06877520
- Acronym / sponsor ID
- TCP-EFS-07-GE
- Conditions
- Tricuspid Regurgitation (TR)
- Keywords
- Pivot Extend, TauMedical
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Tau-MEDICAL Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Mar 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.
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.
- 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.
- Device success, procedural success, and clinical outcomes of long-term implantation of the investigational medical device "Pivot Extend" will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-center, open label, single arm, early feasibility study
| Arm | Type | Receives |
|---|---|---|
| Treatment to Improve TR Symptoms with Investigational Medical Device Implantation | Experimental | Device: Pivot Extend Tricuspid Regurgitation Spacer DeviceParticipants assigned to this arm will receive an investigational medical device designed to improve symptoms of severe and clinically symptomatic tricuspid regurgitation (TR). Following device implantation, participants will be monitored in a specialized facility for at least 24 hours with real-time observation of vital signs. The device's safety and efficacy will be assessed over 12 months through scheduled visits, with clinical progress monitored throughout. Device removal may be performed if adverse events occur or if deemed necessary by the investigator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18 years of age or older at the time of screening
- Those with symptoms despite medical therapy (OMT, diuretics/medications) for TR for at least 1 month at screening
- Those who meet the criteria of severe (3+) or worse on the TR grade classification table on echocardiography performed at the screening visit
- Those with clinical symptoms of New York Heart Association (NYHA) class 2 or worse
- Those deemed suitable for percutaneous valve intervention by a Heart Team that includes at least one cardiologist, one cardiac surgeon and one anesthesiologist.
Key exclusion criteria (25 listed)
- Those with 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
- Those with uncorrected blood clotting disorders based on hemanalysis performed at the screening visit
- Those who are unable to use anticoagulant agents (NOAC ex.Xarelto)
- Those who have had major bleeding (not including minor bleeding, such as a nosebleed that can be hemostasized) treated with anticoagulants prior to participation in this clinical trial
- Those with severe anemia (hemoglobin ≦10g/dL) that requires hospitalization
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 Extend Tricuspid Regurgitation Spacer DeviceThe Pivot Extend Tricuspid Regurgitation Spacer Device is an investigational implant designed to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice and improving leaflet coaptation. The device is implanted via a transcatheter procedure under imaging guidance. Following implantation, participants will undergo post-procedural monitoring for at least 24 hours to ensure safety and device stability. The device is intended for long-term placement, with scheduled follow-up assessments at designated intervals over a 12-month period to evaluate its safety and efficacy. Device removal may be performed if adverse events occur or if deemed necessary by the investigator. | Device | Treatment to Improve TR Symptoms with Investigational Medical Device Implantation |
Primary outcome
Major Adverse Cardiac Events(MACEs)
Time frame: 1 month post-procedure
Occurrence Ratio of Major Adverse Cardiac Events (MACEs)
9 secondary outcomes
Device Success
Time frame: during procedure
Procedural Success(1)
Time frame: 1-month, 6-month, 12-month post-procedure
Procedural Success(2)
Time frame: 1-month, 6-month, 12-month post-procedure
Clinical Outcomes(1)
Time frame: 6-month, 12-month post-procedure
Clinical Outcomes(2)
Time frame: 1-month, 6-month, 12-month post-procedure
Clinical Outcomes(3)
Time frame: 1-month, 6-month, 12-month post-procedure
Clinical Outcomes(4)
Time frame: 1-month, 6-month, 12-month post-procedure
Clinical Outcomes(5)
Time frame: 1-month, 6-month, 12-month post-procedure
Clinical Outcomes(6)
Time frame: 1-month, 6-month, 12-month post-procedure
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 11 Apr 2025.
Related trials for Tricuspid Regurgitation (TR)
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Not yet recruiting
TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Recruiting
The TRICURE US IDE Pivotal Study
Tricuspid Regurgitation (TR)
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pivot Extend Tricuspid Regurgitation Spacer Device in people with Tricuspid Regurgitation (TR), run by Tau-MEDICAL Co., Ltd. at 3 sites in Georgia.
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 7 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 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Georgia. 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 Markus Reinthaler, MD, PhD (+49 (0) 157 37972007, reinthal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events(MACEs) (time frame: 1 month post-procedure). 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 11 Apr 2025.