Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470022
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-13
Brief Title:
Comparison of Evolut FX Versus Sapien 3 Ultra Resilia
Sponsor:
Christian Juhl Terkelsen
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia The Compare-TAVI 2 Trial
Status:
RECRUITING
Status Verified Date:
2024-08
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:
COMPARE-TAVI
Brief Summary:
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia
Detailed Description:
The purpose of the Compare-TAVI organization is to ensure a continuous comparison of the TAVI-valves implanted and to monitor long-term valve performances
Purpose of present study
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia
Hypotheses
1 Evolut FX is non-inferior to Edwards Sapien 3 Resilia with regard to the combined endpoint death stroke moderatesevere aortic regurgitation moderatesevere valve deterioration between the two valves being compared
2 There is no difference between valves in secondary safety and efficacy endpoints see below
3 There is no difference in Aortic Regurgitation fraction ARF and Effective Orifice Area EOA measured by CMR CMR-substudy N166
4 There is no difference in EOA measured invasively during dobutamine stress hemodynamic substudy N440
5 There is no difference in occurrence of Hypoathenuated Leaflet Thickening HALT measured by CT CT-substudy N778
Purpose of present study
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia
Hypotheses
1 Evolut FX is non-inferior to Edwards Sapien 3 Resilia with regard to the combined endpoint death stroke moderatesevere aortic regurgitation moderatesevere valve deterioration between the two valves being compared
2 There is no difference between valves in secondary safety and efficacy endpoints see below
3 There is no difference in Aortic Regurgitation fraction ARF and Effective Orifice Area EOA measured by CMR CMR-substudy N166
4 There is no difference in EOA measured invasively during dobutamine stress hemodynamic substudy N440
5 There is no difference in occurrence of Hypoathenuated Leaflet Thickening HALT measured by CT CT-substudy N778
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None