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

Micro Interventional Devices

Status: Not yet enrolling

Conditions: Tricuspid Regurgitation Functional; Severe Tricuspid Valve Regurgitation; Tricuspid Regurgitation

Treatments: Device: MIA_T Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT06700239

MID-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 3 patient groups

Randomized Cohort TEER

Active Comparator group

Description:

MIA-T vs. TEER

Treatment:

Device: MIA_T Device

Single Arm Cohort

Experimental group

Description:

MIA-T

Treatment:

Device: MIA_T Device

Roll-in

Experimental group

Description:

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

Treatment:

Device: MIA_T Device