

The EARLY TAVR Trial
This trial is no longer enrolling patients
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
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.
Practical challenges with clinical surveillance include:
- Interpreting symptoms is often difficult
- AS progression is variable and rapid deterioration may occur
- Late symptom reporting may result in irreversible myocardial damage with worsened prognosis after AVR
Trial Design
Patients will undergo a treadmill stress test to determine if they are asymptomatic with severe aortic stenosis.
Asymptomatic
Negative stress test* OR confirmation via medical history
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)
Key Study Criteria
- 65 years of age or older
- Severe aortic stenosis defined as:
- Aortic valve area (AVA) ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2
and
- Peak jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg
- Aortic valve area (AVA) ≤ 1.0 cm2 or AVA index ≤ 0.6 cm2/m2
- Patient is asymptomatic defined as:
- Negative treadmill stress test
or
- Physician assessment of patient history if unable to perform a stress test
- Negative treadmill stress test
- LV ejection fraction ≥ 50%
- Society of Thoracic Surgeons (STS) risk score ≤ 10
Patient Screening Process
Investigational Device Information

SAPIEN 3 Valve

SAPIEN 3 Ultra Valve
See how it works

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 this trial, visit NCT03042104 at ClinicalTrials.gov
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.
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