Ignite Creation Date:
2025-12-18 @ 9:46 AM
Ignite Modification Date:
2025-12-23 @ 10:50 PM
Study NCT ID:
NCT04223713
Status:
None
Last Update Posted:
2021-03-04 00:00:00
First Post:
2019-11-29 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
4D- Flow- MRI After Aortic Valve Surgery
Sponsor:
None
Organization:
Study Overview
Official Title:
Changes of Aortic Flow Patterns Detected by 4D- Flow- MRI After Trileaflet Reconstruction of the Aortic Valve With Autologous Pericardium Compared to Prosthetic Valve Replacement With Biological Prosthesis
Status:
None
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
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:
Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) is a new treatment option for diseased aortic valves and offers benefits compared to conventional valve replacement. At the moment no prospective randomized trials evaluating the role of the TriRec procedure are available and factors contributing to long- term durability are unknown.
The investigators want to examine aortic flow patterns with 4D- Flow- Magnetic Resonance Imaging (MRI) in patients after the TriRec procedure or biological prosthetic valve replacement in a prospective randomized trial. Flow patterns in the ascending aorta, examined with 4D- Flow- MRI, show nearly laminar flow patterns and no outflow obstruction in healthy subjects with tricuspid aortic valves. In contrast, helical flow patterns, turbulences and increased flow velocities are observed in diseased valves and also after valve replacement with mechanical or biological prostheses. These helical flow patterns seem to influence aortic wall remodeling and may contribute to structural valve dysfunction of biological prosthesis.
The investigators hypothesize that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis. The results can contribute to understand mechanisms for long- term performance of this technique and determine the role of this novel technique for treatment of aortic valve disease.
The investigators want to examine aortic flow patterns with 4D- Flow- Magnetic Resonance Imaging (MRI) in patients after the TriRec procedure or biological prosthetic valve replacement in a prospective randomized trial. Flow patterns in the ascending aorta, examined with 4D- Flow- MRI, show nearly laminar flow patterns and no outflow obstruction in healthy subjects with tricuspid aortic valves. In contrast, helical flow patterns, turbulences and increased flow velocities are observed in diseased valves and also after valve replacement with mechanical or biological prostheses. These helical flow patterns seem to influence aortic wall remodeling and may contribute to structural valve dysfunction of biological prosthesis.
The investigators hypothesize that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis. The results can contribute to understand mechanisms for long- term performance of this technique and determine the role of this novel technique for treatment of aortic valve disease.
Detailed Description:
None
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?: