Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05751577
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2023-02-21
Brief Title:
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery the TRACS Trial
Sponsor:
Azienda Usl di Bologna
Organization:
Azienda Usl di Bologna
Study Overview
Official Title:
TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery the TRACS Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRACS
Brief Summary:
The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death stroke and rehospitalization for cardiovascular cause The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery did not differ between study arms
Detailed Description:
TRACS is an all-comer prospective randomized multicenter open-label trial with blinded adjudicated evaluation of outcomes PROBE The TRACS trial will involve centers without on-site cardiac surgery but with experienced operators already performing TAVI at the referring center with on-site cardiac surgery Thus participating centers and their study TAVI operators must follow selective criteria for eligibility Participants will be recruited after Heart Team indication to TAVI procedure The eligibility of each single patient to the study MUST BE CONFIRMED and VALIDATED by unanimous decision of the Heart Team Study patients will be randomized in a 21 fashion to TAVI procedure performed by the same experienced operators either in the center without on-site cardiac surgery or in the referring center with on-site cardiac surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None