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

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: Not yet recruiting
• Conditions: Tricuspid Regurgitation; Tricuspid Regurgitation Functional; Severe Tricuspid Valve Regurgitation
• Intervention / Treatment: Device: MIA_T Device

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: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angie Swenson; Phone Number: 215-600-1270; Email: aswenson@microinterventional.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint	Composite endpoint of the following components: All-cause mortality; Tricuspid valve intervention (percutaneous or surgery); Heart Failure Hospitalization	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	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Freedom from all-cause mortality at all study timepoints	1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Freedom from heart failure hospitalizations at all study timepoints	1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Clinical Success Rate	1Month
Intraprocedural Success Rate	1Month
Freedom from Major Adverse Events (MAE) at all study time points.	1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Prevalence of Device or Procedure-Related Adverse Events (AE)	1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Core Lab assessment of change in other pertinent echo	1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in NT-proBNP	1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in gamma-GTP	1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in eGFR	1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in MELD score (liver function)	1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years
Change in SF-36 QoL scores	1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
TR Grade Reduction	Change in TR grade to moderate or less	12 months
KCCQ Reduction	Average change in patients overall KCCQ summary scores by ≥ 10	12 months

Collaborators and Investigators

• Sponsor: Micro Interventional Devices

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2032

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 21, 2024

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: MIA-T; severe TR; severe functional TR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• Other Study ID 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