Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Aortic Valve Stenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Two-cohortMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 65 years and 125 years
- Gender
- Both males and females
Description
Single-arm, two-cohort, descriptive, multi-center, international All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
Single-arm, two-cohort, descriptive, multi-center, international All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.
Tracking Information
- NCT #
- NCT04639258
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Paul Sorajja, MD Allina Health System Principal Investigator: Josep Rodes-Cabau, MD Fondation IUCPQ
Get Well Soon