Heart Valve Diseases Clinical Trial
Official title:
The Prospective LEUVEN Transcatheter Valve Therapy Registry
Assessment of feasibility, safety and outcomes of transcatheter valve interventions
Transcatheter valve therapies have a growing impact on daily medical practice since the first
human percutaneous implantation of an aortic valve bioprosthesis by A. Cribier in 2002. While
initially these techniques were reserved for patients at prohibitive risk for surgical aortic
valve implantation, indications moving toward patients at high and intermediate risk.
Outcomes of these percutaneous interventions need to be monitored to assess quality of care
and tailor indications in this rapidly moving field in interventional cardiology.
Trial objectives and Design Trial objectives
- to describe patient populations selected for transcatheter valve treatment
- to describe procedural aspects and results
- to perform clinical and hemodynamic follow-up of the patients Primary endpoints The
primary endpoints of the study are clinical outcomes after transcatheter valve
interventions according to the Valve Academic Research Consortium criteria (2-3).
Secondary endpoints The secondary endpoints of the study are hemodynamic outcomes after
transcatheter valve interventions according to the Valve Academic Research Consortium
criteria (2-3). Quality of life parameters, as well as exercise tolerance will be assessed.
Trial Design The design of the trial is a prospective non-interventional registry.
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