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The Prospective LEUVEN Transcatheter Valve Therapy Registry

Recruiting
Conditions
Heart Valve Diseases
Interventions
Device: Transcatheter valve intervention
Registration Number
NCT03674788
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
5000
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
TMVITranscatheter valve interventionTranscatheter Mitral Valve Intervention
TAVITranscatheter valve interventionTranscatheter Aortic Valve Implantation
TTVITranscatheter valve interventionTranscatheter Tricuspid Valve Intervention
Primary Outcome Measures
NameTimeMethod
All-cause death10 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 death10 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 causes10 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 stroke10 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 Outcome Measures
NameTimeMethod
Bleeding complicationsearly 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).

Kidney injuryearly 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).

Quality of life10 years of follow-up

EQ5D and EQ-Visual analogue scale

Clinical efficacy10 years of follow-up

Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).

Rehospitalisation for cardiovascular causes10 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).

Myocardial infarctionearly 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).

Time-related valve safety10 years of follow-up

Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).

Stroke10 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).

Vascular complicationsearly 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 arrhythmiasearly 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).

Device success30 days 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

Early safety30 days of follow-up

Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).

Exercise tolerance2 years of follow-up

6-minutes walking test

Trial Locations

Locations (1)

Department of Cardiology, University Hospital Gasthuisberg

🇧🇪

Leuven, Belgium

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