MedTrace Logo

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

NCT02677974 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 510

Last updated 2024-10-08

No results posted yet for this study

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).

Conditions

  • Thrombotic and Bleeding Events

Interventions

DEVICE

On-X Aortic Heart Valve replacement

Aortic valve replacement with low dose warfarin

Sponsors & Collaborators

  • North American Science Associates Inc.

    collaborator UNKNOWN

  • On-X Life Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Goeff Tsang, MBChB · Southampton University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-10
Primary Completion
2027-04-30
Completion
2027-08-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02677974 on ClinicalTrials.gov