The Prospective LEUVEN Transcatheter Valve Therapy Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcatheter valve intervention.
- Who it may be relevant to
- Registry conditions: Heart Valve Diseases. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Device Transcatheter valve intervention
Primary outcome measures
- All-cause death [Time frame: 10 years of follow-up]
- Cardiovascular death [Time frame: 10 years of follow-up]
- All-cause death and/or rehospitalisation for cardiovascular causes [Time frame: 10 years of follow-up]
- All-cause death and/or major stroke [Time frame: 10 years of follow-up]
Secondary outcome measures (12)
- Rehospitalisation for cardiovascular causes [Time frame: 10 years of follow-up]
- Stroke [Time frame: 10 years of follow-up]
- Kidney injury [Time frame: early after index intervention (30 days)]
- Bleeding complications [Time frame: early after index intervention (30 days)]
- Vascular complications [Time frame: early after index intervention (30 days)]
- Myocardial infarction [Time frame: early after index intervention (30 days)]
- Conduction disturbances and arrhythmias [Time frame: early after index intervention (30 days)]
- Quality of life [Time frame: 10 years of follow-up]
- Exercise tolerance [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). [Time frame: 10 years of follow-up]
- Device success [Time frame: 30 days of follow-up]
- Early safety [Time frame: 30 days of follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- Department of Cardiology, University Hospital Gasthuisberg — Leuven
Identifiers
NCT: NCT03674788 · S61523