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

NCT06700239 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: MID-004
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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 estimated risk for mortality and morbidity with tricuspid valve surgery.

Conditions

Tricuspid Regurgitation Functional; Tricuspid Regurgitation; Severe Tricuspid Valve Regurgitation

Keywords

MIA-T; severe TR; severe functional TR

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• 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

Other Outcomes (2)

• TR Grade Reduction

  12 months

• KCCQ Reduction

  12 months

Study Arms (3)

Randomized Cohort TEER

ACTIVE COMPARATOR

MIA-T vs. TEER

Device: MIA_T Device

Single Arm Cohort

EXPERIMENTAL

MIA-T

Device: MIA_T Device

Roll-in

EXPERIMENTAL

MIA-T device for physicians training prior to initiating randomized cohort enrollment.

Device: MIA_T Device

Interventions

MIA_T Device DEVICE

MIA-T Device

Randomized Cohort TEER; Roll-in; Single Arm Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Micro Interventional Devices: lead

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Angie Swenson

CONTACT

215-600-1270; aswenson@microinterventional.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 21, 2024
• Study Start: December 31, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2032
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share