Clinical trials: Mechanical Heart Valve Prosthesis
Heart Valve Disease
Prospective Randomized On-X Versus SJM Evaluation Trial
The study hypothesizes that rate of thromboembolic complications of the On-X prosthesis is reduced as compared to the SJM prosthesis.
- Trial name
- PROSE (NCT00639782)
- Testing
- On-X Heart valve replacement, SJM Heart valve replacement
- Where
- 28 sites in United States, Australia and 7 more
- Volunteers
- 857 people
- Sponsor
- On-X Life Technologies, Inc.
Heart Valve Diseases
Dabigatran Etexilate in Patients With Mechanical Heart Valves
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.
- Trial name
- RE-ALIGN (NCT01452347)
- Testing
- warfarin 1mg, dabigatran etexilate intermediate dose, dabigatran etexilate low dose
- Where
- 40 sites in Belgium, Canada and 8 more
- Volunteers
- 328 people
- Sponsor
- Boehringer Ingelheim
Thromboembolism, Heart Valve Prosthesis
Follow on Study From RE-ALIGN
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.
- Trial name
- NCT01505881
- Testing
- dabigatran etexilate low dose, warfarin 5mg, dabigatran etexilate intermediate dose
- Where
- 30 sites in Belgium, Canada and 7 more
- Volunteers
- 158 people
- Sponsor
- Boehringer Ingelheim