The Prospective LEUVEN Transcatheter Valve Therapy Registry

Heart Valve Diseases Clinical Trial

— LEUVEN-TVT  

Official title:

The Prospective LEUVEN Transcatheter Valve Therapy Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03674788
• Other study ID #: S61523
• Status: Recruiting
• Start date: March 12, 2008
• Est. completion date: December 31, 2037

Study information

• Verified date: July 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Christophe Dubois, MD, PhD
• Email: christophe.dubois[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Assessment of feasibility, safety and outcomes of transcatheter valve interventions

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 information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2037
• Est. primary completion date: December 31, 2037
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Device:
• Transcatheter valve intervention

Locations

Country	Name	City	State
Belgium	Department of Cardiology, University Hospital Gasthuisberg	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	10 years of follow-up
Primary	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).	10 years of follow-up
Primary	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).	10 years of follow-up
Primary	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).	10 years of follow-up
Secondary	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).	10 years of follow-up
Secondary	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).	10 years of follow-up
Secondary	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).	early after index intervention (30 days)
Secondary	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).	early after index intervention (30 days)
Secondary	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).	early after index intervention (30 days)
Secondary	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).	early after index intervention (30 days)
Secondary	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).	early after index intervention (30 days)
Secondary	Quality of life	EQ5D and EQ-Visual analogue scale	10 years of follow-up
Secondary	Exercise tolerance	6-minutes walking test	2 years of follow-up
Secondary	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	10 years of follow-up
Secondary	Device success	Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).	30 days of follow-up
Secondary	Early safety	Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).	30 days of follow-up
Secondary	Clinical efficacy	Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).	10 years of follow-up
Secondary	Time-related valve safety	Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).	10 years of follow-up