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.