Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597188
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
TAVR Vs SAVR Study of VitaFlow Liberty for Severe BAV Stenosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Transcatheter Aortic Valve Replacement with Surgical Aortic Valve Replacecment a Prospective Multicenter International Randomized Controlled Non-inferiority Study for Bicuspid Aortic Valve Stenosis PROMIS-BAV
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
PROMIS-BAV
Brief Summary:
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system VitaFlow Liberty for the treatment of severe bicuspid aortic valve BAV stenosis
Detailed Description:
Transcatheter aortic valve replacement TAVR has emerged as the first-line treatment for symptomatic severe AS currently while TAVR for bicuspid aortic valve BAV stenosis has not been well demonstrated in randomized controlled trials thus more randomized controlled studies of TAVR vs SAVR are still needed to provide strong evidence that TAVR treatment for patients with BAV stenosis has good safety and effectiveness
This study is a prospective international multicenter randomized controlled non-inferiority clinical study in which the study device VitaFlow Liberty for TAVR is to be demonstrated as non-inferior to the control device a commercially available surgical bioprosthetic valve for SAVR in terms of the incidence of composite endpoint events all-cause mortality all strokes and re-hospitalizations at 12 months postoperatively
In this study 420 eligible subjects will be randomly assigned to the study group n210 or the control group n210 in a 11 ratio The subjects in study group will be treated with the TAVR surgery using the study device VitaFlow Liberty while the subjects in control group will be treated with the SAVR surgery using the control device a commercially available surgical bioprosthetic valve and clinical follow-ups will be performed at discharge or 7 days after surgery 30 days 6 months 12 months and 2 3 4 5 years after surgery respectively
This study is a prospective international multicenter randomized controlled non-inferiority clinical study in which the study device VitaFlow Liberty for TAVR is to be demonstrated as non-inferior to the control device a commercially available surgical bioprosthetic valve for SAVR in terms of the incidence of composite endpoint events all-cause mortality all strokes and re-hospitalizations at 12 months postoperatively
In this study 420 eligible subjects will be randomly assigned to the study group n210 or the control group n210 in a 11 ratio The subjects in study group will be treated with the TAVR surgery using the study device VitaFlow Liberty while the subjects in control group will be treated with the SAVR surgery using the control device a commercially available surgical bioprosthetic valve and clinical follow-ups will be performed at discharge or 7 days after surgery 30 days 6 months 12 months and 2 3 4 5 years after surgery respectively
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