On-X Aortic Prosthetic Heart Valve Registry
Research type
Research Study
Full title
On-X® Aortic Prosthetic Heart Valve Low Dose Warfarin Post Approval Clinical Registry Study
IRAS ID
191532
Contact name
Geoff Tsang
Contact email
Sponsor organisation
On-X Life Technologies Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 11 months, 20 days
Research summary
The purpose of this registry study is to assess the occurrence of bleeding, valve thrombosis [clots forming on the valve] and valve-related thromboembolism [clots breaking off into the circulation] in patients having routine insertion of an On-X Aortic Prosthesis Heart Valve. Usual practice has been to maintain patient clotting profile with an INR [measurement of time to form clot] of 2.0 - 3.0. Whilst this reduces the risk of thromboembolism, it is associated with a risk of bleeding. A previous study [IDE-G050208] in a group of patients at increased risk of thromboembolism [based on clinical and laboratory data] who were maintained at a lower INR [target 1.5 to 2.0] has shown a reduced composite rate of bleeding and thromboembolism. As a result of this IDE the CE mark was updated to include the low INR labelling. This registry study seeks to answer the question “do the results of the study translate into standard practice in all-comers?” Patients will be under standard anticoagulation for at least 3 months before initiation of a low dose anticoagulation treatment of INR range of 1.8 [range 1.5 to 2.0](Standard practice). Patients will be followed for 5 year by telephone interview. The global study will recruit patients from the UK, Europe, Canada and United States. It will assess subset comparisons amongst patients using home monitoring of their coagulation and those attending coagulation clinics [e.g. at GP surgery]. In the UK, home monitoring is not an option so patients in the UK will be in the clinic monitoring arm.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0191
Date of REC Opinion
11 Sep 2017
REC opinion
Further Information Favourable Opinion