Study ID: EARLY TAVR
Evaluation of transcatheter aortic valve replacement compared to surveillance for patients with asymptomatic severe aortic stenosis (EARLY TAVR)
The EARLY TAVR clinical trial is for patients with severe aortic stenosis who have not yet exhibited any clinical signs or symptoms associated with the disease. Currently asymptomatic patients do not qualify to receive a TAVR, and so this study seeks to determine if there is in fact a benefit of early valve replacement vs. waiting for symptoms to appear.
The clinical standard of care for patients with severe aortic stenosis who do not have symptoms involves continued surveillance and waiting for symptoms to evolve before considering replacing the valve. The purpose of this study is to determine if these patients benefit from having a transcatheter aortic valve replacement (TAVR) vs. waiting for symptoms to develop.
Patients who enroll in this study are required to perform a treadmill stress test, which will validate if the patient has symptoms. Those who remain asymptomatic during the stress test (i.e., they maintain normal heart rate, blood pressure or breathing during exercise) will have the opportunity to enroll in the clinical trial and be randomly assigned to one of two arms: TAVR arm or clinical surveillance. Those in the TAVR trial arm will receive the Edwards SAPIEN Transcatheter Heart Valve. Other factors are also taken into consideration when determining eligibility into the clinical trial.
A prospective, randomized, controlled, multi-center study to establish the safety and effectiveness of the Edwards SAPIEN Transcatheter Heart Valve compared with clinical surveillance in asymptomatic patients with severe, calcific aortic stenosis. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) vs. continual medical management. Patients will be stratified by whether or not they are able to perform a treadmill stress test, utilizing the Bruce protocol. In addition, patients screened for enrollment but then found to have a positive stress test will be followed in a registry where subsequent data re: treatment and mortality will be collected.
- Must be 65 years or older
- Must have severe, calcific aortic valve stenosis
- Must have no related symptoms
Additional criteria may apply.