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

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).
NCT02677974
Heart & Vascular - Cardiac Surgery, Heart & Vascular
Eric Lehr, MD
Andrea Drouhard
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with On-X aortic heart valve replacements implanted within the prior year.
Criteria

Inclusion Criteria:

  1. Adult patients (age 18 years or older) who have only an On-X aortic prosthetic heart valve (ONXA, ONXAE, ONXAC, ONXACE, ONXAN, ONXANE) implant, without or without concomitant procedures, and agreed to participate in the registry.
  2. Life expectancy of at least 5 years.
  3. Patients whose operation occurred within the year prior to recruitment.

Exclusion Criteria:

  1. Patients having any other type of prosthetic valve implant (isolated or in combination with another valve(s)) or any On-X mitral valve; i.e. no mitral or multiple valve implants.
  2. Patients with a prior history of arterial thromboembolic events, or who have such events or On-X valve thrombosis after AVR and prior to recruitment.
  3. Death prior to discharge or recruitment.
  4. Patients whose surgery predates enrollment by more than 1 year.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with On-X aortic heart valve replacements implanted within the prior year.
Criteria

Inclusion Criteria:

  1. Adult patients (age 18 years or older) who have only an On-X aortic prosthetic heart valve (ONXA, ONXAE, ONXAC, ONXACE, ONXAN, ONXANE) implant, without or without concomitant procedures, and agreed to participate in the registry.
  2. Life expectancy of at least 5 years.
  3. Patients whose operation occurred within the year prior to recruitment.

Exclusion Criteria:

  1. Patients having any other type of prosthetic valve implant (isolated or in combination with another valve(s)) or any On-X mitral valve; i.e. no mitral or multiple valve implants.
  2. Patients with a prior history of arterial thromboembolic events, or who have such events or On-X valve thrombosis after AVR and prior to recruitment.
  3. Death prior to discharge or recruitment.
  4. Patients whose surgery predates enrollment by more than 1 year.
Andrea Drouhard
206-215-3982
206-215-1500