Translational Pathways for Cardiovascular Devices – Session III: The Endpoints for Translational Mitral/Tricuspid Valve Device Development Practice Quiz – ISCTR | International Society for Cardiovascular Translational Research

When regulatory agencies are evaluating devices for mitral/tricuspid repair or replacement:

Long term efficacy endpoints for mitral/tricuspid devices are:

Survival, rehospitalization and device embolization
Mortality, rehospitalization, quality of life and left ventricular ejection fraction
Quality of life, mortality and access related complication
All of the above

Quality of life assessment is considered a safety endpoint

Which of the following is correct?

Device success means that the implant performs as intended without device related complication; measurement occurs at discharge
Procedural success means device success without major adverse events; measurement starts at discharge and lasts for 3 months
Technical success means device success and returning to pre-procedure environment; measurement occurs at the exit from procedure
Individual success; measurement occurs at the exit from procedure