NCT04889872

PROGRESS: Management of Moderate Aortic Stenosis by Clinical Surveillance or TAVR

The PROGRESS Trial: A Prospective, Randomized, Controlled Trial to Assess the Management of Moderate Aortic Stenosis by Clinical Surveillance or Transcatheter Aortic Valve Replacement

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,250 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Detailed description

This is a prospective, randomized, controlled, multicenter study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 / SAPIEN 3 Ultra /SAPIEN 3 Ultra RESILIA THV or Clinical Surveillance.

Conditions

• Aortic Stenosis, Calcific
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA	Patients will be implanted with a SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA heart valve

Timeline

• Start date: 2021-10-12
• Primary completion: 2029-06-01
• Completion: 2037-06-01
• First posted: 2021-05-17
• Last updated: 2025-12-17

Locations

80 sites across 6 countries: United States, Australia, Canada, Japan, Netherlands, Switzerland

Regulatory

• FDA-regulated device study