Health TrialsbyHealthPanel

The Prospective LEUVEN Transcatheter Valve Therapy Registry

ConditionHeart Valve Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

Assessment of feasibility, safety and outcomes of transcatheter valve interventions

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry

Disqualifiers

All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry. There are no formal exclusion criteria.

Trial population

Patients undergoing transcatheter valve intervention

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transcatheter valve intervention

    Device

Treatment groups

5,000 Participants
are divided into 3 treatment groups
Group A: TAVI1 intervention
Group B: TMVI1 intervention
Group C: TTVI1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
10 years of follow-up
2

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).

Time frame
10 years of follow-up
3

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).

Time frame
10 years of follow-up
4

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).

Time frame
10 years of follow-up

Secondary outcomes

1

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).

Time frame
10 years of follow-up
2

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).

Time frame
10 years of follow-up
3

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).

Time frame
early after index intervention (30 days)
4

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).

Time frame
early after index intervention (30 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
Apply now