HVP_PROACT PAS Low Dose

HVP PROACT 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).

Key Inclusion Criteria:

1. Adult patients (age 18 years or older) who have only an On-X aortic prosthetic heart valve 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.

**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Phase IV/V
NCT02677974
Heart and Vascular
Valvular Heart Disease
Eric Kirker, M.D.
On-X Life Technologies
Michelle Dixon
  • Providence Portland Medical Center
  • Providence St. Vincent Medical Center