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Clinical Trial Summary

The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04573660
Study type Observational
Source Abbott Medical Devices
Contact Sharan Dhanjal
Phone +1 714-926-8292
Email sharanjeet.dhanjal@abbott.com
Status Recruiting
Phase
Start date October 25, 2020
Completion date November 2031

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