Clinical trials

2

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Condition / disease
Location
Status: Not yet recruiting

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

Participants needed: 600
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Micro Interventional DevicesUpdated: Nov 26, 2025
Eligibility criteria

Subject has severe functional TR (≥ 3). Note: If any cardiac procedure(s) occur... [+2]

Systolic pulmonary artery pressure (sPAP) > 70 mmHg or > 5 wood units (WU) despi... [+10]

Status: Recruiting

Study of Transcatheter Tricuspid Annular Repair

The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.

Participants needed: 60
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Micro Interventional DevicesUpdated: Oct 23, 2024Locations: 6
Eligibility criteria

Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tric... [+7]

Pregnant or lactating female [+20]