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The EARLY TAVR Trial

This trial is no longer enrolling patients

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lady consultation
lady consultation
early tavr logo
early tavr logo
early tavr logo
A Clinical Trial for Severe Aortic Stenosis Patients Who Have No Symptoms

Trial objective

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

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

Trial background

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

old man challenges
old man challenges
old man challenges

Practical challenges with clinical surveillance include:

  1. Interpreting symptoms is often 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.

Trial design

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

Asymptomatic graphic
Asymptomatic graphic
Asymptomatic graphic

Asymptomatic

Negative stress test* OR confirmation via medical history

trial design symptomatic
trial design symptomatic
trial design symptomatic

Symptomatic

Positive stress test*

*For patients who can perform treadmill stress test

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thinking woman
thinking woman

Key study criteria

thinking woman
thinking woman
thinking woman
  • 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
      or
    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

Patient screening process

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 Valve

SAPIEN 3 Transcatheter Heart Valve

SAPIEN 3 Ultra Valve
SAPIEN 3 Ultra Valve
SAPIEN 3 Ultra Valve

SAPIEN 3 Ultra Transcatheter Heart Valve

See how it works

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contact us lady
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We're here for you

We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center. For details about the trial, visit NCT03042104 at Clinical Trials.gov.

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888.713.1564

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Caution: Investigational device

Caution: Investigational device

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.