Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcatheter Tricuspid Valve Replacement: All patients undergoing Transcatheter Tricuspid Valve Replacement for native tricuspid valve disease

Study summary

The field of transcatheter tricuspid valve replacement (TTVR) is rapidly emerging and data on this topic are scarce. Particularly, little is known about which patients are at greatest risk of procedural complications, such as the timing and onset of conduction disturbances necessitating permanent pacemaker implantation, and how such patients are managed. On this background, the TRIPLACE Registry - an investigator-initiated global multicenter registry - is aimed at better understanding the safety and efficacy of orthotopic TTVR.

Eligibility

Primary outcome measure(s)

• Freedom from device-related complications — 30 days after the index procedure
  Freedom from device-related complications will be determined by assessing the number of participants with procedural, peri-procedural and device-related complications
• Reduction in Tricuspid Regurgitation Severity — 30 days after the index procedure
  Tricuspid Regurgitation measured by transthoracic echocardiography. Assessment of MI severity according to current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Tricuspid Regurgitation is measured by transthoracic echocardiography in accordance with current guidelines (ESC/EACTS and ACC/AHA) for valvular heart disease. Mean tricuspid regurgitation severity will be determined using the following scale: 0=none/trace; 1=mild; 2=moderate; 3=severe; 4=massive; 5=torrential. Change from baseline tricuspid regurgitation severity score 30 days after baseline will be assessed

Trial sites (31)

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