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. 2019 May 21;14(2):54–61. doi: 10.15420/icr.2019.5.1

Table 1: Ongoing Studies on Transcatheter Tricuspid Regurgitation Treatment.

Device Study Patients Primary endpoints
MitraClip TRILUMINATE (NCT03227757) 85 Echocardiographic TR reduction ≥1 grade (30 days), composite of MAE (6 months)
MitraClip for Severe TR (NCT02863549) 100 Echocardiographic TR grade and MACCE (1–12 months)
Forma SPACER (NCT02787408) 78 Cardiac mortality at 30 days, compared to literature-derived performance goal based on surgical outcomes
Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System (NCT02471807) 60 Device success and freedom from device or procedure related SAEs at 30 days
Cardioband TRI-REPAIR (NCT02981953) 30 Successful access, deployment, positioning and septolateral diameter reduction (intra-procedural), major SAEs and SADE (30 days)
Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study (NCT03382457) 15 Freedom from device or procedure-related adverse events (30 days)
TriBAND (NCT03779490) 150 TR at discharge (approximately 2-8 days post-procedure)
DaVingi FiH Study of the DaVingi™ TR System in the Treatment of Patients With Functional Tricuspid Regurgitation (NCT03700918) 15 Implant technical success as successful adjustment of the ring at the annulus (post-procedure), Incidence and severity of SADE (30 days)
Trialign SCOUT II (NCT03225612) 60 All-cause mortality at 30 days
TriCinch Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System (NCT03294200) 90 All-cause mortality at 30 days
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System (NCT03632967) (USA study) 15 All-cause mortality at 30 days
MIA STTAR (not registered) 40 Rate of MAEs at 30 days, technical success rate and reduction in valve area
CAVI with Sapien HOVER (NCT02339974) 15 Procedural success including device success and no device/procedure related SAEs (30 days), Individual patient success defined by device success and clinical outcomes/improvements
CAVI with TricValve TRICUS (NCT03723239) 10 MAEs at 30 days, Change of NYHA functional class at 6 months

CAVI = caval valve implantation; MACCE = major adverse cardiac and cerebrovascular events; MAE = major adverse events; SADE = serious adverse device effects; SAE = severe adverse event; TR = tricuspid regurgitation.