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

NCT01812174 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-06

Study results available
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Summary

This study examines the hemodynamic and hemolytic properties of two additional smaller size valves to the On-X line of valves already approved by FDA.

Conditions

  • Heart Valve Disease

Interventions

DEVICE

17mm aortic valve (On-X )

Heart aortic valve replacement surgery: 17mm Aortic

DEVICE

23mm mitral valve (On-X)

Heart mitral valve replacement surgery: 23mm Mitral

Sponsors & Collaborators

  • On-X Life Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Sidney Levitsky, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-18
Primary Completion
2018-12-07
Completion
2018-12-07

Countries

  • United States
  • Puerto Rico
  • Spain

Study Locations

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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 NCT01812174 on ClinicalTrials.gov