STTAR CLINICAL TRIALS

STTAR - THE STUDY OF TRANSCATHETER TRICUSPID ANNULAR REPAIR IN EUROPE

STTAR is a non-randomized, multi-center CE-Mark study that evaluates the safety and performance of MIA-T for the treatment of tricuspid regurgitation.

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STTAR-US - THE STUDY OF TRANSCATHETER TRICUSPID ANNULAR REPAIR IN THE UNITED STATES

MID is preparing for a US Clinical Trial studying the safety and efficacy of MIA-T.  The technology has received FDA Breakthrough Designation in December 2019.  The company anticipates receipt of approval to commence a US study in 2021.

 

The Study of Transcatheter Tricuspid Annular Repair

The STTAR study is enrolling patients at six clinical sites throughout Europe. This study is currently ongoing. Safety profile is high; there have been no serious device-related adverse events peri-procedurally or during follow up. There has been significant and durable reductions in tricuspid regurgitation and annular dimensions have been achieved and maintained at one-year follow-up. The technology treats a wide range of functional TR patients with minimal exclusion criteria. 

MIA™ is an Investigational Device ONLY. The technology has been submitted for CE Mark approval.  The company hopes to commercialize the product in 2021.

STARR

EUROPEAN STTAR CLINICAL TRIAL SITES

Study of Transcatheter Tricuspid Annular Repair

Santaos Klinikos, Vilnius, Lithuania

VILNIUS UNIVERSITY HOSPITAL

Kaunas, Lithuania

KAUNAS UNIVERSITY HOSPITAL

Budapest, Hungary

SEMMELWEIS UNIVERSITY

Warsaw, Poland

CARDINAL WYSZYNSKI NATIONAL INSTITUTE OF CARDIOLOGY

Riga, Latvia

PAULS STRADINS CLINICAL UNIVERSITY HOSPITAL

Aarhus. Denmark

AARHUS UNIVERSITY HOSPITAL DENMARK