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Heart Valve

17mm aortic valve (On-X ) for Valvular Heart Disease

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

Patients who require an isolated aortic valve replacement size 17 mm or isolated mitral valve replacement size 23mm.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-year

Awards & highlights

Study Summary

This trial looks at how well two new, smaller valves work compared to existing valves.

Eligible Conditions

Valvular Heart Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You need a replacement for either your aortic valve (if it's less than 17 mm) or your mitral valve (if it's less than 23 mm).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Valve Related Adverse Events at 1 Year

Secondary outcome measures

Diagnosis of Valve Thrombosis at 1 Year

Trial Design

2Treatment groups

Experimental Treatment

Group I: 23mm On-X Mitral Heart ValveExperimental Treatment1 Intervention

Patients receiving the 23mm On-X mitral heart valve as a replacement for diseased native or prosthetic mitral heart valve. Enrollment into the 23mm On-X mitral arm has been terminated.

Group II: 17mm On-X Aortic Heart ValveExperimental Treatment1 Intervention

Patients receiving the 17mm On-X aortic heart valve as a replacement for diseased native or prosthetic aortic heart valve.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

On-X Life Technologies, Inc.Lead Sponsor

3 Previous Clinical Trials

2,567 Total Patients Enrolled

2 Trials studying Valvular Heart Disease

2,057 Patients Enrolled for Valvular Heart Disease

Sidney Levitsky, MDStudy ChairBeth Israel Deaconess Medical Center

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what geographic regions are the experiments of this study being conducted?

"Currently, 4 medical sites are open for patient enrollment. These locations include Portland, Cincinnati and Charlottesville as well as other urban zones. To limit the need of travelling far distances it is preferable to join a clinic located in your vicinity."

Answered by AI

Are there vacancies remaining in this research investigation?

"As evidenced on clinicaltrials.gov, this trial is no longer actively recruiting patients; it was first posted in November 2011 and last edited in September 2022. Nonetheless, there are presently 53 other medical studies that candidates can participate in."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

On-X Heart Valve - 17mm Aortic and 23mm Mitral

2011. "On-X Heart Valve - 17mm Aortic and 23mm Mitral". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01812174.