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Clinical Trial

On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study

NCT: NCT02677974 · ACTIVE_NOT_RECRUITING

NCT IDNCT02677974
StatusACTIVE_NOT_RECRUITING
Start Date2015-11-10
SponsorOn-X Life Technologies, Inc. (INDUSTRY)
First posted
Last updated

Brief Summary

The purpose of the proposed study is to assess the occurrence of bleeding, valve-related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period. The objective will be to compare adverse event rates for patients in subgroups as listed below targeted at 1.8 (range 1.5 to 2.0) per On-X instructions for use to rates from the previous IDE trial (G050208).

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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