The Prospective LEUVEN Transcatheter Valve Therapy Registry
LEUVEN-TVT
1 other identifier
observational
5,000
1 country
1
Brief Summary
Assessment of feasibility, safety and outcomes of transcatheter valve interventions
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 12, 2008
CompletedFirst Submitted
Initial submission to the registry
July 17, 2018
CompletedFirst Posted
Study publicly available on registry
September 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2037
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2037
July 3, 2024
July 1, 2024
29.8 years
July 17, 2018
July 2, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (14)
Rehospitalisation for cardiovascular causes
10 years of follow-up
Stroke
10 years of follow-up
Kidney injury
early after index intervention (30 days)
Bleeding complications
early after index intervention (30 days)
Vascular complications
early after index intervention (30 days)
- +9 more secondary outcomes
Study Arms (3)
TAVI
Transcatheter Aortic Valve Implantation
TMVI
Transcatheter Mitral Valve Intervention
TTVI
Transcatheter Tricuspid Valve Intervention
Interventions
Eligibility Criteria
Patients undergoing transcatheter valve intervention
You may qualify if:
- All patients selected for percutaneous treatment of a valve disorder potentially qualify for the present registry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiology, University Hospital Gasthuisberg
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2018
First Posted
September 18, 2018
Study Start
March 12, 2008
Primary Completion (Estimated)
December 31, 2037
Study Completion (Estimated)
December 31, 2037
Last Updated
July 3, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share