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Not yet recruiting NCT06700239

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

No phase Interventional Tricuspid Regurgitation Functional Tricuspid Regurgitation Severe Tricuspid Valve Regurgitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MIA_T Device.
Who it may be relevant to
Registry conditions: Tricuspid Regurgitation Functional, Tricuspid Regurgitation, Severe Tricuspid Valve Regurgitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • Device MIA_T Device
    MIA-T Device

Primary outcome measures

  • Primary Efficacy Endpoint [Time frame: 12 months]
  • Primary Safety Endpoint [Time frame: 30 days]
Secondary outcome measures (12)
  • Freedom from all-cause mortality at all study timepoints [Time frame: 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]
  • Clinical Success Rate [Time frame: 1Month]
  • Intraprocedural Success Rate [Time frame: 1Month]
  • Freedom from Major Adverse Events (MAE) at all study time points. [Time frame: 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]
  • Core Lab assessment of change in other pertinent echo [Time frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
  • Change in NT-proBNP [Time frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
  • Change in gamma-GTP [Time frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
  • Change in eGFR [Time frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
  • Change in MELD score (liver function) [Time frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]
  • Change in SF-36 QoL scores [Time frame: 1Month, 6Month, 12Month, 2Years, 3Years, 4Years, and 5Years]

Eligibility criteria

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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06700239 · MID-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗