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Prosthetic Heart Valve

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

N/A
Waitlist Available
Research Sponsored by On-X Life Technologies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

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).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Major bleeds
Thrombotic events
Secondary study objectives
Death

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: On-X Aortic Heart Valve replacementExperimental Treatment1 Intervention
Patients with On-X Aortic Valve maintained on low dose warfarin anticoagulation with an INR target of 1.5 to 2.0, with or without home monitoring.

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Who is running the clinical trial?

On-X Life Technologies, Inc.Lead Sponsor
3 Previous Clinical Trials
2,077 Total Patients Enrolled
North American Science Associates Inc.UNKNOWN
2 Previous Clinical Trials
1,433 Total Patients Enrolled
Goeff Tsang, MBChBStudy DirectorSouthampton University
~101 spots leftby Apr 2027
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