Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-03-01 @ 10:10 AM
Study NCT ID:
NCT03021356
Status:
COMPLETED
Last Update Posted:
2017-01-13
First Post:
2017-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of TrIfecta and Perimount Magna Ease
Sponsor:
Kerckhoff Klinik
Organization:
Study Overview
Official Title:
Prospective Randomized Comparison of TrIfecta and Perimount Magna Ease
Status:
COMPLETED
Status Verified Date:
2017-01
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:
None
Brief Summary:
The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: