The Prospective LEUVEN Transcatheter Valve Therapy Registry
- Conditions
- Heart Valve Diseases
- Interventions
- Device: Transcatheter valve intervention
- Registration Number
- NCT03674788
- Lead Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry
- All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry. There are no formal exclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description TMVI Transcatheter valve intervention Transcatheter Mitral Valve Intervention TAVI Transcatheter valve intervention Transcatheter Aortic Valve Implantation TTVI Transcatheter valve intervention Transcatheter Tricuspid Valve Intervention
- Primary Outcome Measures
Name Time Method All-cause death 10 years of follow-up The primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Cardiovascular death 10 years of follow-up The primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
All-cause death and/or rehospitalisation for cardiovascular causes 10 years of follow-up The primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
All-cause death and/or major stroke 10 years of follow-up The primary endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
- Secondary Outcome Measures
Name Time Method Bleeding complications early after index intervention (30 days) BARC classification. The endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Kidney injury early after index intervention (30 days) AKIN classification. The endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Quality of life 10 years of follow-up EQ5D and EQ-Visual analogue scale
Clinical efficacy 10 years of follow-up Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Rehospitalisation for cardiovascular causes 10 years of follow-up The endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Myocardial infarction early after index intervention (30 days) The endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Time-related valve safety 10 years of follow-up Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Stroke 10 years of follow-up The endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Vascular complications early after index intervention (30 days) The endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Conduction disturbances and arrhythmias early after index intervention (30 days) The endpoints of the study are clinical outcomes after transcatheter valve interventions according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Device success 30 days of follow-up Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Valvular function according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18). 10 years of follow-up Mean and peak gradient (mmHg) Effective orifice area (cm²) Left ventricular ejection fraction (%) valvular regurgtiation
Early safety 30 days of follow-up Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Exercise tolerance 2 years of follow-up 6-minutes walking test
Trial Locations
- Locations (1)
Department of Cardiology, University Hospital Gasthuisberg
🇧🇪Leuven, Belgium