Clinical trials investigating the use of new devices for tricuspid regurgitation
| Device | Clinical trial (NCT#) | Primary endpoint |
|---|---|---|
| Tricuspid valve repair system (Abbott Medical Devices) | TRILUMINATE (NCT03227757) | Tricuspid regurgitation reduction ≥ 1 grade at 1 month Composite of major adverse events at 6 months |
| PASCAL (Edwards Lifesciences) | Edwards CLASP TR EFS (NCT03745313) | Freedom from device or procedure-related adverse events at 1 month |
| TriCinch system (4Tech Cardio Ltd.) | PREVENT (NCT02098200) | Safety: The percentage of participants with major adverse events within 30 days of the procedure Performance: The reduction in the degree of tricuspid regurgitation measured immediately after the procedure compared with baseline |
| Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System (NCT03294200) | All-cause mortality at 1 month | |
| TriAlign (Mitralign Inc.) | PTVAS (SCOUT-II) (NCT03225612) | Incidence of all-cause mortality at 30 days |
| Cardioband (ValtechCardio) | TRI-REPAIR (NCT02981953) | The overall rate of major serious adverse events and serious adverse device effects at 30 days. Successful access, deployment and positioning of the Cardioband device and septolateral dimension reduction intraprocedurally. Change in septolateral dimension at 30 days. |
| Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study (NCT03382457) | Freedom from device or procedure-related adverse events at 30 days. | |
| MIA (Micro Interventional Devices Inc.) | STTAR (NCT03692598) | Safety: Major adverse event at 1 month Performance: The technical success rate of MIA implant and reduction in the valve area |
MIA = minimally invasive annuloplasty; PREVENT = Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System; PTVAS = Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System; TRILUMINATE = Clinical Trial to Evaluate Cardiovascular Outcomes In Patients Treated With the Tricuspid Valve Repair System; TRI-REPAIR = Tricuspid Regurgitation Repair With Cardioband Transcatheter System; STTAR = Study of Transcatheter Tricuspid Annular Repair
Source: Data from clinicaltrials.gov