An observational study in Heart Valve Diseases, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational
Assessment of feasibility, safety and outcomes of transcatheter valve interventions
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
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.
535 studies on the registry are indexed under Heart Valve Diseases; 173 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 300 across 232 observational studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients undergoing transcatheter valve intervention
Exclusion Criteria:
Transcatheter Aortic Valve Implantation
Device: Transcatheter valve intervention
Transcatheter Mitral Valve Intervention
Device: Transcatheter valve intervention
Transcatheter Tricuspid Valve Intervention
Device: Transcatheter valve intervention
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 10 years of follow-up
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: early after index intervention (30 days)
Quality of life
EQ5D and EQ-Visual analogue scale
Time frame: 10 years of follow-up
Exercise tolerance
6-minutes walking test
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 10 years of follow-up
Plan to share: No
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Universitaire Ziekenhuizen KU Leuven