NCT02738853

The Medtronic TAVR 2.0 US Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement

Detailed description

Prospective, single arm, multi-site study. Patients will be seen at pre and post procedure, discharge, 30 days, 6 months, 1 year, and annually up to 5 years.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic Transcatheter Aortic Valve 2.0 Replacement System	Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-11-01
• Completion: 2021-12-15
• First posted: 2016-04-14
• Last updated: 2023-03-21
• Results posted: 2018-02-08

Locations

8 sites across 1 country: United States