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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2032-12-31

Brief Summary

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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.

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Detailed Description

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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

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Tricuspid Regurgitation Functional Tricuspid Regurgitation Severe Tricuspid Valve Regurgitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Randomized Cohort TEER

MIA-T vs. TEER

Group Type ACTIVE_COMPARATOR

MIA_T Device

Intervention Type DEVICE

MIA-T Device

Single Arm Cohort

MIA-T

Group Type EXPERIMENTAL

MIA_T Device

Intervention Type DEVICE

MIA-T Device

Roll-in

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

Group Type EXPERIMENTAL

MIA_T Device

Intervention Type DEVICE

MIA-T Device

Interventions

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MIA_T Device

MIA-T Device

Intervention Type DEVICE

Eligibility Criteria

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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%

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No