Clinical trial NCT03674788: The Prospective LEUVEN Transcatheter Valve Therapy Registry
Official title: The Prospective LEUVEN Transcatheter Valve Therapy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Valve Diseases
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing transcatheter valve intervention

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.

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.

Primary outcomes:
measure: All-cause death
timeFrame: 10 years of follow-up
measure: Cardiovascular death
timeFrame: 10 years of follow-up
measure: All-cause death and/or rehospitalisation for cardiovascular causes
timeFrame: 10 years of follow-up
measure: All-cause death and/or major stroke
timeFrame: 10 years of follow-up
Secondary outcomes:
measure: Rehospitalisation for cardiovascular causes
timeFrame: 10 years of follow-up
measure: Stroke
timeFrame: 10 years of follow-up
measure: Kidney injury
timeFrame: early after index intervention (30 days)
measure: Bleeding complications
timeFrame: early after index intervention (30 days)
measure: Vascular complications
timeFrame: early after index intervention (30 days)
measure: Myocardial infarction
timeFrame: early after index intervention (30 days)
measure: Conduction disturbances and arrhythmias
timeFrame: early after index intervention (30 days)
measure: Quality of life
timeFrame: 10 years of follow-up
measure: Exercise tolerance
timeFrame: 2 years of follow-up
measure: Valvular function according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
timeFrame: 10 years of follow-up
measure: Device success
timeFrame: 30 days of follow-up
measure: Early safety
timeFrame: 30 days of follow-up
measure: Clinical efficacy
timeFrame: 10 years of follow-up
measure: Time-related valve safety
timeFrame: 10 years of follow-up
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Cardiology, University Hospital Gasthuisberg
Study officials:
References: