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.
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.
EUROPEAN STTAR CLINICAL TRIAL SITES
Study of Transcatheter Tricuspid Annular Repair
Santaos Klinikos, Vilnius, Lithuania
VILNIUS UNIVERSITY HOSPITAL
KAUNAS UNIVERSITY HOSPITAL
CARDINAL WYSZYNSKI NATIONAL INSTITUTE OF CARDIOLOGY
PAULS STRADINS CLINICAL UNIVERSITY HOSPITAL