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AF Ablation Study for Rapid CE Mark

  • CE mark for innovative AF ablation devices requires statistically powered studies with appropriate endpoints and follow-up
  • Meditrial supported a global medical device companies to collect the CE mark data in less than 2 years
“I wanted to SINCERELY thank you for everything you have done for this project. It is so helpful to know that you are on top of things on the Meditrial's end, and I truly enjoyed working with you! Thank you”
  • The Meditrial electronic CRF Catchtrial, was used to collect multicenter data at  sites in New Zealand, South America and Europe, allowing the CE-mark application.
  • Catchtrial allowed web-based images transfer for DICOM files (TTE, TEE, CT scan), with a Protected health information (PHI) automatic anonymization.
  • The system is compliant with US regulation, 21 CFR part 11 .
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