The Prospective LEUVEN Transcatheter Valve Therapy Registry (LEUVEN-TVT)

Universitaire Ziekenhuizen KU Leuven

Status

Enrolling

Conditions

Heart Valve Diseases

Treatments

Device: Transcatheter valve intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03674788

S61523

Details and patient eligibility

About

Assessment of feasibility, safety and outcomes of transcatheter valve interventions

Full description

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.

Enrollment

5,000 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry

Exclusion criteria

All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry. There are no formal exclusion criteria.