Heart Valve Diseases
Conditions
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.
Interventions
DEVICETranscatheter valve intervention
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
| 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). |
| Quality of life | 10 years of follow-up | EQ5D and EQ-Visual analogue scale |
| Exercise tolerance | 2 years of follow-up | 6-minutes walking test |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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 |
| 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). |
| 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). |
| 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). |
Countries
Belgium
Contacts
Primary ContactChristophe Dubois, MD, PhD
Backup ContactMarina Claes
Outcome results
None listed