The EARLY TAVR trial

A Clinical Trial for Severe Aortic Stenosis Patients Who Have No Symptoms

About the Trial

The EARLY TAVR Trial will examine the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve (THV) versus careful observation (or clinical surveillance) in patients with severe aortic stenosis without symptoms.

The purpose of the trial is to compare results of patients that have their valves replaced early in the disease process versus patients that have the disease monitored.

Download Patient Information Guide

Severe Aortic Stenosis with No Symptoms

Aortic stenosis is a buildup of calcium deposits on the valve leaflets, which causes the valve to narrow and reduce blood flow to the rest of your body.

Many patients with severe aortic stenosis experience symptoms, while others have no symptoms (or are asymptomatic). The symptoms of aortic stenosis are often misunderstood by patients as “normal” signs of aging. Many patients may appear to not have symptoms, but on closer examination, many do have symptoms.

Healthy Aortic Valve
Healthy Aortic Valve

Diseased Aortic Valve
Diseased Aortic Valve
(With calcium buildup)

Are you a candidate?

You may be eligible for this trial if:

  • you are 65 years of age or older
  • you have severe aortic stenosis
  • you do not have symptoms.
Find a Clinical Research Hospital

Your doctor or research coordinator will discuss with you the full list of criteria for participating in the trial.

For Patients who have severe aortic stenosis and have no symptoms, a treadmill stress test helps to understand if there are symptoms during mild exercise. This test involves walking on a treadmill while your heart, blood pressure, and breathing are monitored by your doctor

Man talking with doctor

  1. What screening tests will be done?
  2. What are the possible risks and benefits of the TAVR procedure?
  3. What are the possible risks and benefits of monitoring my disease (or clinical surveillance)?
  4. How often will I need to have follow-up visits?
  5. How long will the trial last?

Additional information

Additional Information

For more detailed information about the EARLY TAVR Trial please visit: www.clinicaltrials.gov

View more details

CAUTION: INVESTIGATIONAL DEVICES. The Edwards SAPIEN 3 / Edwards SAPIEN 3 Ultra transcatheter heart valve is an investigational device when used in asymptomatic patients. Limited by Federal (USA) law to investigational use only. These devices are not available for marketing or commercial sale in the United States for asymptomatic patients. See instructions for use for full information, including indications, contraindications, warnings, precautions, and adverse events.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, SAPIEN, SAPIEN 3 and SAPIEN 3 Ultra are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks or service marks are the property of their respective owners.

© 2021 Edwards Lifesciences Corporation. All rights reserved. PP--US-5809 v1.0

Edwards Lifesciences ∙ One Edwards Way, Irvine CA 92614 USA

Please update your browserClose this window

Please update to a current version of your preferred browser, this site will perform effectively on the following:

Unable to update your browser?

If you are on a computer, that is maintained by an admin and you cannot install a new browser, ask your admin about it. If you can't change your browser because of compatibility issues, think about installing a second browser for browsing and keep this old one for compatibility