Tricuspid Regurgitation FunctionalSTTAR-USNCT06700239
The STTAR-US Study: A Pivotal Study of Transcatheter Tricuspid Annular Repair in the US
A study testing MIA_T Device in people with Tricuspid Regurgitation Functional and Tricuspid Regurgitation, run by Micro Interventional Devices.
Trial summary
Purpose of this clinical study is to demonstrate the safety and efficacy of MIA-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR grade ≥3) despite optimal medical therapy, who have been determined by the site's local heart team to be at intermediate or greater… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation Functional, Tricuspid Regurgitation, Severe Tricuspid Valve Regurgitation
- What is being tested?
- MIA_T Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 31 Dec 2025to Dec 2032
- Phase
- Interventional
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
- Subject has severe functional TR (≥ 3). Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after any cardiac procedure(s)
- In the judgment of the site's local heart team patient is at intermediate or greater risk for morbidity \& mortality with tricuspid valve surgery, and has been adequately treated per applicable standards with optimized medical therapy for the treatment of TR (e.g. diuretics) and stable for at least 30 days prior to enrollment.
- New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
Who cannot join
- Systolic pulmonary artery pressure (sPAP) > 70 mmHg or > 5 wood units (WU) despite vasodilator therapy
- Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg
- Previous tricuspid valve repair or replacement (transcatheter or surgical approach)
- Subjects with concomitant left-sided valve disease will have the option of receiving a left-sided intervention (e.g. TMVR or TAVR) and waiting 60 days prior to being reassessed for the study
- Myocardial infarction (MI), known unstable angina, symptomatic coronary artery disease (CAD) where revascularization is possible within 60 days prior to enrollment
- Anatomy that precludes safe placement of anchors around the annulus
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- Hemodynamic instability defined as systolic pressure < 90 mmHg requiring pressor support within the last 30 days
- Echo Criteria -
- Subject has severe functional TR (determined by the ICL). Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after any cardiac procedure(s)
- No presence of Cardiac Implantable Electronic Devices (CIED) leads causing the TR
- No significant annular calcification
- Left Ventricular Ejection Fraction (LVEF) ≥ 20%
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Purpose of this clinical study is to demonstrate the safety and efficacy of MIA-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR grade ≥3) despite optimal medical therapy, who have been determined by the site's local heart team to be at intermediate or greater estimated risk for mortality and morbidity with tricuspid valve surgery.
Read the detailed description
A prospective, multi-center, randomized, controlled, pivotal study of the MIA Percutaneous Tricuspid Annuloplasty System (MIA-T) in symptomatic subjects with severe (≥3) TR despite optimal medical therapy.
The study will randomize eligible subjects in two (2) cohorts at up to 40 sites.
- Conditions
- Tricuspid Regurgitation Functional, Tricuspid Regurgitation, Severe Tricuspid Valve Regurgitation
- Being tested
- MIA_T Device
- Keywords
- MIA-T, severe TR, severe functional TR
- 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.
MIA_T DeviceDevice
MIA-T Device
| Study group | Role | What they receive |
|---|---|---|
| Randomized Cohort TEER | Active comparator | MIA-T vs. TEER Receives: Device: MIA_T Device |
| Single Arm Cohort | Experimental | MIA-T Receives: Device: MIA_T Device |
| Roll-in | Experimental | MIA-T device for physicians training prior to initiating randomized cohort enrollment. Receives: Device: MIA_T Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
Composite endpoint of the following components:
- All-cause mortality
- Tricuspid valve intervention (percutaneous or surgery)
- Heart Failure Hospitalization
Measured: 12 months
Primary Safety Endpoint
Freedom from MAE, including:
- Cardiovascular mortality
- New Onset Renal Failure
- Endocarditis requiring surgery
- Non-elective cardiovascular surgery for device-related AE post-index procedure
Measured: 30 days
Secondary outcomes (12)
Freedom from all-cause mortality at all study timepoints
Measured: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Freedom from heart failure hospitalizations at all study timepoints
Measured: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Clinical Success Rate
Measured: 1Month
Intraprocedural Success Rate
Measured: 1Month
Freedom from Major Adverse Events (MAE) at all study time points.
Measured: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Prevalence of Device or Procedure-Related Adverse Events (AE)
Measured: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Core Lab assessment of change in other pertinent echo
Measured: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in NT-proBNP
Measured: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in gamma-GTP
Measured: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in eGFR
Measured: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in MELD score (liver function)
Measured: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in SF-36 QoL scores
Measured: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start31 Dec 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation FunctionalStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two cohorts One (1) cohort will randomize subjects at a 1:1 ratio against commercially available TEER Device (control group). One (1) cohort is a single arm cohort for patients deemed unfavorable for TEER and the local heart team determines the patient is not optimal for valve replacement.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Micro Interventional Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700239
- Sponsor's protocol ID
- MID-004
- Acronym
- STTAR-US
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2024
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No