Clinical Trial

EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

Study acronym: EARLY TAVR
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
This study will evaluate 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.
Protocol Amendment History 47 amendments
This ClinicalTrials.gov record has been amended 47 times since 2017-02-01; most recent amendment 2025-04-08.
Status change: Recruiting → Active, Not Recruiting 2022-01-21
Status change: Not Yet Recruiting → Recruiting 2017-08-18
Trial Details
NCT Number NCT03042104
Lead Sponsor Edwards Lifesciences
Conditions Heart Diseases, Aortic Stenosis, Severe
Enrollment 901 participants
Start Date 2017-07-12
Primary Completion 2024-03-31 (estimated)
Study Completion 2032-03 (estimated)
Updated on ClinicalTrials.gov 2024-05-13