EU-MDR Cardiovascular Collaboratory
The EU-MDR Cardiovascular Collaboratory (EU-MCVC) is an international expert network which brings together European academicians, clinical trialists, and regulatory experts to collaborate with clinical research stakeholders, regionally and globally.
The purpose of EU-MCVC is to create a dynamic and open conversation to continuously achieve an effective implementation of clinical research in Europe with emphasis on navigating the European Medical Device Regulation (EU-MDR). Relevant stakeholders to this collaboratory are cardiovascular research organizations, registry platforms, regulatory bodies, and industry partners.
EU-MCVC Board
- Dr. Ernest Spitzer - Cardialysis & European Cardiovascular Research Institute (ECRI Foundation) (Rotterdam, The Netherlands)
- Prof. dr. David Erlinge - Department of Cardiology, Lund University Hospital (Lund, Sweden)
- Dr. Armando Pérez de Prado - Hospital Universitario de León & EPIC Foundation (Leon, Spain)
- Prof. Jan G.P. Tijssen - Cardialysis & European Cardiovascular Research Institute (ECRI Foundation)
Deliverables 2023-2025
The deliverables of EU-MCVC include:
- Yearly educational meeting
- Develop on-line resources
- Yearly white paper or publication
- Develop the EU-MCVC Registry Network
- Participation in international working groups
Accomplishments 2023-2025
First think tank on Use of Cardiovascular Registries Data in European Regulatory Pathways: Part I, which took place in Rotterdam on September 8th, 2023, including 13 Faculty and 42 registered participants, representing 9 European countries and 12 countries globally.
Faculty Picture in Rotterdam
Next steps: White paper in preparation.
Structural Heart Core Lab
The Cardialysis Structural Heart Core Lab provides the perfect partner in conducting transcatheter therapies clinical trials (e.g. TAVR, TMTT). Over the past few years thousands of imaging data from patients enrolled in several registries and clinical trials have been successfully analyzed and adjudicated by the Cardialysis Core Lab. These data are used for CE mark and FDA submissions.
Investigator Initiated Studies
The European Cardiovascular Research Institute (ECRI) offers a platform for the design and conduct of international investigator-initiated clinical trials. ECRI acts as Sponsor ensuring compliance with ICH GCP guidelines and regulatory standards. Trial activities are executed by Cardialysis alone or in collaboration with renowned research organizations world-wide.
Monitoring Services
Cardialysis offers a consolidated monitoring network across Europe. Our clinical research associates ensure timely activation of investigational sites, high-quality data review and effective interaction with sites. With >1400 sites monitored and >200,000 patients included, Cardialysis has established a significant track record in site management.