TAVR Clinical Trials
The safety and effectiveness of the Edwards SAPIEN® Valve in a TAVR procedure were evaluated in a randomized, controlled pivotal study called the PARTNER Trial.
In September 2010, The New England Journal of Medicine published results showing that the Edwards SAPIEN Valve had a significantly lower mortality rate than standard medical therapy for "inoperable" patients.
- Seven out of every 10 inoperable patients with severe aortic stenosis were alive one year after the procedure.
- In comparison, only five out of every 10 patients who did not receive a new valve (part of the control group) were alive at one year.
- Patients treated with the Edwards SAPIEN Valve had improved heart function and improved quality of life at one year, as compared to patients not treated with the valve.
The Heart & Vascular Institute-Texas Medical Center is one of only three sites in Texas involved in the PARTNER II Trial, a research study that enables our affiliated physicians to place a new smaller version of the SAPIEN® valve in patients who qualify for the procedure. The results of this study are anticipated to show that the new valve offers patients who meet the criteria even better outcomes than the SAPIEN valve currently approved by the FDA, including a shorter hospital stay, improved heart function, and improved quality of life at one year. For more info on trials, please call 713.704.TAVR.