NCT05149755

Evolut™ EXPAND TAVR II Pivotal Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

Detailed description

Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.

Conditions

• Moderate Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT)	Patients will have a Transcatheter Aortic Valve Replacement (TAVR) with either an Evolut PRO+ TAVR, or Evolut FX TAVR, heart valve, and given clinical site-determined guideline-directed management and therapy (GDMT).

Timeline

• Start date: 2022-04-27
• Primary completion: 2027-09-01
• Completion: 2034-12-01
• First posted: 2021-12-08
• Last updated: 2026-03-17

Locations

94 sites across 16 countries: United States, Australia, Austria, Belgium, Canada, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated device study