On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
NCT: NCT02677974 · ACTIVE_NOT_RECRUITING
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).
Frequently Asked Questions
What is On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study?
On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study is a clinical trial registered under NCT02677974. Current status: ACTIVE_NOT_RECRUITING.
What is the status of NCT02677974?
The current status of NCT02677974 (On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study) is: ACTIVE_NOT_RECRUITING.
When did On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study start?
On-X Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study started on 2015-11-10.
Related Devices
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.