NCT03674788

The Prospective LEUVEN Transcatheter Valve Therapy Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Assessment of feasibility, safety and outcomes of transcatheter valve interventions

Detailed 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.

Conditions

• Heart Valve Diseases

Interventions

Type	Name	Description
DEVICE	Transcatheter valve intervention

Timeline

• Start date: 2008-03-12
• Primary completion: 2037-12-31
• Completion: 2037-12-31
• First posted: 2018-09-18
• Last updated: 2024-07-03

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated device study