Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-30 @ 6:00 PM
Study NCT ID:
NCT06861361
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical vs Transcatheter Aortic Valve Replacement in Young Patients
Sponsor:
Ceric Sàrl
Organization:
Study Overview
Official Title:
Surgical Bioprosthesis Aortic Valve Replacement Vs. Myval Balloon-Expandable THV Series in Patients Aged 65 to 75 With Symptomatic Severe Aortic Stenosis Judged Eligible by Heart Team
Status:
RECRUITING
Status Verified Date:
2025-12
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:
START YOUNG
Brief Summary:
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
Detailed Description:
Prospective, randomized, multinational, multicenter, open label, trial of 1180 patients treated with surgical bioprosthetic aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).
Study Oversight
Has Oversight DMC:
True
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?: