PERIGON Pivotal Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 650
Summary
- Conditions
- Aortic Stenosis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a prospective, interventional, non-randomized, worldwide, multi-center trial, with each site following a common protocol. A maximum of 1300 subjects will be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial will include male and female patients of legal age to provid...
This is a prospective, interventional, non-randomized, worldwide, multi-center trial, with each site following a common protocol. A maximum of 1300 subjects will be implanted at a maximum of 40 sites in the US, Europe and Canada. The trial will include male and female patients of legal age to provide informed consent in the country where they enroll in the trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic aortic valve. Subjects will be followed out to 5 years and select sites will follow subjects out to 12 years. Enrollment is currently open to capture additional data sets for the size 29mm valve only.
Tracking Information
- NCT #
- NCT02088554
- Collaborators
- Medtronic
- Investigators
- Principal Investigator: Joseph Sabik, MD University Hospital Cleveland Medical Center (Not a recruiting site) Principal Investigator: Prof. Dr. Robert Johannes Menno Klautz, MD Leiden University Medical Center
Get Well Soon