The STTAR-US Study: A Pivotal Study of Transcatheter Tricuspid Annular Repair in the US (STTAR-US)

November 24, 2025 updated by: Micro Interventional Devices
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Randomized Cohort TEER
MIA-T vs. TEER
Device: MIA_T Device
MIA-T Device
Experimental: Single Arm Cohort
MIA-T
Device: MIA_T Device
MIA-T Device
Experimental: Roll-in
MIA-T device for physicians training prior to initiating randomized cohort enrollment.
Device: MIA_T Device
MIA-T Device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Efficacy Endpoint
Time Frame: 12 months

Composite endpoint of the following components:

  • All-cause mortality
  • Tricuspid valve intervention (percutaneous or surgery)
  • Heart Failure Hospitalization
12 months
Primary Safety Endpoint
Time Frame: 30 days

Freedom from MAE, including:

  • Cardiovascular mortality
  • New Onset Renal Failure
  • Endocarditis requiring surgery
  • Non-elective cardiovascular surgery for device-related AE post-index procedure
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Freedom from all-cause mortality at all study timepoints
Time Frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Freedom from heart failure hospitalizations at all study timepoints
Time Frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Clinical Success Rate
Time Frame: 1Month
1Month
Intraprocedural Success Rate
Time Frame: 1Month
1Month
Freedom from Major Adverse Events (MAE) at all study time points.
Time Frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Prevalence of Device or Procedure-Related Adverse Events (AE)
Time Frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Core Lab assessment of change in other pertinent echo
Time Frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in NT-proBNP
Time Frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in gamma-GTP
Time Frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in eGFR
Time Frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in MELD score (liver function)
Time Frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in SF-36 QoL scores
Time Frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TR Grade Reduction
Time Frame: 12 months
Change in TR grade to moderate or less
12 months
KCCQ Reduction
Time Frame: 12 months
Average change in patients overall KCCQ summary scores by ≥ 10
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Micro Interventional Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MID-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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