Database design

The HVS Mitral Tricuspid Valve Database is designed as an ambispective observational cohort study, in which patients can be included retrospective, with both retrospective and prospective follow-up, or entirely prospectively. Participating centers can contribute consecutively or based on an initiated project. Centers all over the world who are interested can participate.

 

Key features of the Mitral Tricuspid Valve Database

Based on global standard

Variables based on the global standard heart valve disease dataset of the International Consortium for Health Outcomes Measurement (ICHOM).

Scientific responsibility

Under scientific responsibility of the Heart Valve Society (HVS).

Ownership data

Each individual center remains owner of its submitted data and can upload retrospective patients from the local database.

Hosting

Hosting by Castor EDC.
Castor is an electronic database capture system for securely maintaining research data in an online case report form (CRF).

Complies with legislation

The database complies with all applicable laws and regulations, including ICH E6 Good Clinical Practice (GCP), 21 CFR Part 11, EU Annex 11, General Data Protection Regulation (GDPR), HIPAA (US), ISO 9001 and ISO 27001.

Multi center research

Active participants are allowed to perform research using multicenter data.

Patient population

The HVS Mitral and Tricuspid Valve Database is a registry that collects data on the characteristics, procedural information, and outcomes of patients (18+) with mitral and/or tricuspid valve disease who undergo surgical or transcatheter interventions. The registry is open to centers that perform these interventions. Patients can be included consecutively, or project based. 

Data collection

Patient characteristics
  • Diagnosis of mitral and/or tricuspid valve disease
  • Potential risk factors for operative mortality (EuroSCORE)
Procedural data
  • Detailed peri-procedural data
  • Echocardiographic parameters
  • MRI parameters 
  • Additional clamp session
  • Complications at discharge
Follow-up data
  • Clinical data including complications and reintervention
  • Longitudinal echocardiographic and MRI parameters