NCT03042104

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

Evaluation of Transcatheter Aortic Valve Replacement Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 901 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, randomized, controlled, multicenter study. Patients will be randomized to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 / SAPIEN 3 Ultra THV or clinical surveillance. Patients will be stratified by whether they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

Conditions

• Heart Diseases
• Aortic Stenosis, Severe

Interventions

Type	Name	Description
DEVICE	Edwards SAPIEN 3 / SAPIEN 3 Ultra THV	Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.

Timeline

• Start date: 2017-07-12
• Primary completion: 2024-03-31
• Completion: 2032-03-01
• First posted: 2017-02-03
• Last updated: 2024-05-13

Locations

77 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study