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NCT Number: NCT03674788

The Prospective LEUVEN Transcatheter Valve Therapy Registry

Assessment of feasibility, safety and outcomes of transcatheter valve interventions

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Key information

Conditions

Heart Valve Diseases Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiology, University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Stefan Janssens, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcatheter valve intervention

Device

Primary outcomes

  1. All-cause death

    Time frame: 10 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).

  2. Cardiovascular death

    Time frame: 10 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).

  3. All-cause death and/or rehospitalisation for cardiovascular causes

    Time frame: 10 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).

  4. All-cause death and/or major stroke

    Time frame: 10 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 outcomes

  1. Rehospitalisation for cardiovascular causes

    Time frame: 10 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).

  2. Stroke

    Time frame: 10 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).

  3. Kidney injury

    Time frame: early 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).

  4. Bleeding complications

    Time frame: early 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).

  5. Vascular complications

    Time frame: early 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).

  6. Myocardial infarction

    Time frame: early 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).

  7. Conduction disturbances and arrhythmias

    Time frame: early 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).

  8. Quality of life

    Time frame: 10 years of follow-up

    EQ5D and EQ-Visual analogue scale

  9. Exercise tolerance

    Time frame: 2 years of follow-up

    6-minutes walking test

  10. 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

    Mean and peak gradient (mmHg) Effective orifice area (cm²) Left ventricular ejection fraction (%) valvular regurgtiation

  11. Device success

    Time frame: 30 days of follow-up

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

  12. Early safety

    Time frame: 30 days of follow-up

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

  13. Clinical efficacy

    Time frame: 10 years of follow-up

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

  14. Time-related valve safety

    Time frame: 10 years of follow-up

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Dubois, MD, PhD

CONTACT

[email protected]

Marina Claes

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: LEUVEN-TVT

Important dates

Study start
2008
Primary completion
2037
Study completion
2037
First posted
Sep 18, 2018
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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