The Prospective LEUVEN Transcatheter Valve Therapy Registry

NCT ID: NCT03674788

Last Updated: 2024-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-03-12

Study Completion Date

2037-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Assessment of feasibility, safety and outcomes of transcatheter valve interventions

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Valve Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TAVI

Transcatheter Aortic Valve Implantation

Transcatheter valve intervention

Intervention Type DEVICE

TMVI

Transcatheter Mitral Valve Intervention

Transcatheter valve intervention

Intervention Type DEVICE

TTVI

Transcatheter Tricuspid Valve Intervention

Transcatheter valve intervention

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcatheter valve intervention

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Cardiology, University Hospital Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christophe Dubois, MD, PhD

Role: CONTACT

Marina Claes

Role: CONTACT

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S61523

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The TRICURE EU Pivotal Study
NCT06581471 RECRUITING NA
Saint Luc Valve Registry
NCT02974218 UNKNOWN
SwissTAVI Registry
NCT01368250 RECRUITING