EARLY TAVR Trial HCP | Edwards Lifesciences

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

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

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* 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)

*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
  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

Woman thinking

Patient Screening Process

*For patients who can perform treadmill stress test

Investigational Device Information

SAPIEN 3 Valve

SAPIEN 3 Ultra Valve

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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 this trial, visit NCT03042104 at ClinicalTrials.gov

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(888) 713-1564

Send us an email

patient_support@edwards.com

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.