The Prospective LEUVEN Transcatheter Valve Therapy Registry

Study Overview
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Brief Summary
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Assessment of feasibility, safety and outcomes of transcatheter valve interventions

Detailed Description
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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.

Official Title
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The Prospective LEUVEN Transcatheter Valve Therapy Registry

Conditions
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Heart Valve Diseases

Intervention / Treatment
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* Device: Transcatheter valve intervention


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TAVI<br>Transcatheter Aortic Valve Implantation | Device: Transcatheter valve intervention<br> <br> |
| TMVI<br>Transcatheter Mitral Valve Intervention | Device: Transcatheter valve intervention<br> <br> |
| TTVI<br>Transcatheter Tricuspid Valve Intervention | Device: Transcatheter valve intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | 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). | 10 years of follow-up | 
| Cardiovascular death | 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). | 10 years of follow-up | 
| All-cause death and/or rehospitalisation for cardiovascular causes | 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). | 10 years of follow-up | 
| All-cause death and/or major stroke | 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). | 10 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalisation for cardiovascular causes | 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). | 10 years of follow-up | 
| Stroke | 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). | 10 years of follow-up | 
| Kidney injury | 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). | early after index intervention (30 days) | 
| Bleeding complications | 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). | early after index intervention (30 days) | 
| Vascular complications | 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). | early after index intervention (30 days) | 
| Myocardial infarction | 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). | early after index intervention (30 days) | 
| Conduction disturbances and arrhythmias | 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). | early after index intervention (30 days) | 
| Quality of life | EQ5D and EQ-Visual analogue scale | 10 years of follow-up | 
| Exercise tolerance | 6-minutes walking test | 2 years of follow-up | 
| Valvular function according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18). | Mean and peak gradient (mmHg) Effective orifice area (cm²) Left ventricular ejection fraction (%) valvular regurgtiation | 10 years of follow-up | 
| Device success | Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18). | 30 days of follow-up | 
| Early safety | Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18). | 30 days of follow-up | 
| Clinical efficacy | Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18). | 10 years of follow-up | 
| Time-related valve safety | Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18). | 10 years of follow-up |