Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518681
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-04
Brief Title:
Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Multicenter Randomized Controlled Noninferiority Clinical Trial Evaluating the Safety and Efficacy of Prosthetic Polymer Heart Valves for the Treatment of Aortic Valve Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to conduct the initial clinical investigation of the HeartHill Medicals polymer aortic valve namely PoliaVavleto collect evidence on the devices safety and performance
Detailed Description:
The polymer aortic valve PoliaValve from HeartHIll Medical is indicated as a replacement for patients with severe aortic valve disease including severe aortic stenosis severe aortic regurgitation or both These patients will be included in the study after systematic assessment that the subjects meet the criteria for inclusion in the study These patients will be followed up to 5 years after implantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None