The EARLY TAVR trial

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

Trial Objective

To establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis

Download EARLY TAVR Trial HCP Brochure

Trial Background

Recommended treatment for patients with asymptomatic stenosis (AS) are to be followed clinically until they become symptomatic, left ventricular dysfunction develops, or cardiac surgery is recommended for other reasons.

Practical challenges with clinical surveillance:

  1. Interpreting symptoms may be difficult
  2. AS progression is variable and rapid deterioration may occur
  3. Late symptom reporting may result in irreversible myocardial damage with worsened prognosis after AVR

Whether early intervention before symptoms develop will improve outcomes remains unknown and has never been studied in a randomized trial.

Doctor shaking hands with patient

Trial Design

Patients will undergo a treadmill stress test to determine if they are asymptomatic with severe aortic stenosis.

Asymptomatic

Negative stress test* and review Medical History

randomization chart

Primary Endpoint

2 year composite of all-cause death, all stroke, and unplanned cardiovascular hospitalization

Symptomatic

Positive stress test*

Registry

Commerical AVR (TAVR or SAVR)

*For patients who can perform treadmill stress test

Key Study Criteria

  • 65 years of age or older
  • Severe aortic stenosis defined as:
    1. Aortic valve area (AVA) ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2
      and
    2. Peak jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg
  • Patient is asymptomatic defined as:
    1. Negative treadmill stress test
      and
    2. Physician assessment of patient history if unable to perform a stress test
  • LV ejection fraction ≥ 50%
  • Society of Thoracic Surgeons (STS) risk score ≤ 10

Woman thinking

Patient Screening Process

Patient Screening Process

Patient Screening Process

*For patients who can perform treadmill stress test

Investigational Device Information

SAPIEN 3 Valve

SAPIEN 3 Valve

SAPIEN 3 Ultra Valve

SAPIEN 3 Ultra Valve

See how it works

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-5815 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