Heart Valve DiseasesLEUVEN-TVTNCT03674788
The Prospective LEUVEN Transcatheter Valve Therapy Registry
An observational study of Heart Valve Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Assessment of feasibility, safety and outcomes of transcatheter valve interventions Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- Transcatheter valve intervention
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Mar 2008to 31 Dec 2037
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing transcatheter valve intervention
Who may be able to join
- All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry
Who cannot join
- All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry. There are no formal exclusion criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Christophe Dubois, MD, PhD contact
Marina Claes contact
Belgium1 site, 1 recruiting
- Recruiting
Department of Cardiology, University Hospital Gasthuisberg
Leuven, 3000
Stefan Janssens, MD, PhD
About this study
Assessment of feasibility, safety and outcomes of transcatheter valve interventions
Read the 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.
- Conditions
- Heart Valve Diseases
- Being tested
- Transcatheter valve intervention
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter valve interventionDevice
| Study group | Role | What they receive |
|---|---|---|
| TAVI | Transcatheter Aortic Valve Implantation Receives: Device: Transcatheter valve intervention | |
| TMVI | Transcatheter Mitral Valve Intervention Receives: Device: Transcatheter valve intervention | |
| TTVI | Transcatheter Tricuspid Valve Intervention Receives: Device: Transcatheter valve intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 10 years of follow-up
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).
Measured: 10 years of follow-up
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).
Measured: 10 years of follow-up
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).
Measured: 10 years of follow-up
Secondary outcomes (14)
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).
Measured: 10 years of follow-up
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).
Measured: 10 years of follow-up
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).
Measured: early after index intervention (30 days)
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).
Measured: early after index intervention (30 days)
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).
Measured: early after index intervention (30 days)
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).
Measured: early after index intervention (30 days)
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).
Measured: early after index intervention (30 days)
Quality of life
EQ5D and EQ-Visual analogue scale
Measured: 10 years of follow-up
Exercise tolerance
6-minutes walking test
Measured: 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).
Mean and peak gradient (mmHg) Effective orifice area (cm²) Left ventricular ejection fraction (%) valvular regurgtiation
Measured: 10 years of follow-up
Device success
Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Measured: 30 days of follow-up
Early safety
Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Measured: 30 days of follow-up
Clinical efficacy
Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Measured: 10 years of follow-up
Time-related valve safety
Combined endpoint according to the Valve Academic Research Consortium 2 criteria (Eur Heart J. 2012 Oct;33(19):2403-18).
Measured: 10 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start12 Mar 2008
- Primary completion31 Dec 2037 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674788
- Sponsor's protocol ID
- S61523
- Acronym
- LEUVEN-TVT
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2018
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective LEUVEN Transcatheter Valve Therapy Registry
- ClinicalTrials.gov ID
- NCT03674788
- Acronym / sponsor ID
- LEUVEN-TVT / S61523
- Conditions
- Heart Valve Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 12 Mar 2008 (actual)
- Primary completion
- 31 Dec 2037 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAVI | – | Device: Transcatheter valve interventionTranscatheter Aortic Valve Implantation |
| TMVI | – | Device: Transcatheter valve interventionTranscatheter Mitral Valve Intervention |
| TTVI | – | Device: Transcatheter valve interventionTranscatheter Tricuspid Valve Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing transcatheter valve intervention
Key inclusion criteria (1 listed)
- All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry
Key exclusion criteria (1 listed)
- All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry. There are no formal exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter valve intervention | Device | TAVI, TMVI, TTVI |
Primary outcome
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).
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).
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).
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).
14 secondary outcomes
Rehospitalisation for cardiovascular causes
Time frame: 10 years of follow-up
Stroke
Time frame: 10 years of follow-up
Kidney injury
Time frame: early after index intervention (30 days)
Bleeding complications
Time frame: early after index intervention (30 days)
Vascular complications
Time frame: early after index intervention (30 days)
Myocardial infarction
Time frame: early after index intervention (30 days)
Conduction disturbances and arrhythmias
Time frame: early after index intervention (30 days)
Quality of life
Time frame: 10 years of follow-up
Exercise tolerance
Time frame: 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
Device success
Time frame: 30 days of follow-up
Early safety
Time frame: 30 days of follow-up
Clinical efficacy
Time frame: 10 years of follow-up
Time-related valve safety
Time frame: 10 years of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christophe Dubois, MD, PhD contact
Marina Claes contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe Dubois, MD, PhD (christophe.dubois@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death (time frame: 10 years of follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.