The Prospective LEUVEN Transcatheter Valve Therapy Registry (LEUVEN-TVT)

September 14, 2018 updated by: Universitaire Ziekenhuizen KU Leuven
Assessment of feasibility, safety and outcomes of transcatheter valve interventions

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Recruiting
        • Department of Cardiology, University Hospital Gasthuisberg
        • Principal Investigator:
          • Stefan Janssens, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing transcatheter valve intervention

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TAVI
Transcatheter Aortic Valve Implantation
Device: Transcatheter valve intervention
TMVI
Transcatheter Mitral Valve Intervention
Device: Transcatheter valve intervention
TTVI
Transcatheter Tricuspid Valve Intervention
Device: Transcatheter valve intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 years of follow-up
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).
10 years of follow-up
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).
10 years of follow-up
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).
10 years of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
10 years of follow-up
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).
10 years of follow-up
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).
early after index intervention (30 days)
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).
early after index intervention (30 days)
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).
early after index intervention (30 days)
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).
early after index intervention (30 days)
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).
early after index intervention (30 days)
Quality of life
Time Frame: 10 years of follow-up
EQ5D and EQ-Visual analogue scale
10 years of follow-up
Exercise tolerance
Time Frame: 2 years of follow-up
6-minutes walking test
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
Mean and peak gradient (mmHg) Effective orifice area (cm²) Left ventricular ejection fraction (%) valvular regurgtiation
10 years of follow-up
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).
30 days of follow-up
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).
30 days of follow-up
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).
10 years of follow-up
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).
10 years of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2008

Primary Completion (Anticipated)

December 31, 2037

Study Completion (Anticipated)

December 31, 2037

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

September 14, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 14, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S61523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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