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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.
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.
Cardialysis offers a consolidated monitoring network across Europe. Our clinical research associates with >5 years of experience, ensure timely activation of investigational sites, high-quality data review and effective interaction with sites. With >1400 sites monitored and >150,000 patients included, Cardialysis has established a significant track record in site management.