4D- Flow- MRI After Aortic Valve Surgery
Primary Purpose
Aortic Valve Disease
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
TriRec
Aortic valve replacement
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Disease focused on measuring aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, aortic flow patterns, MRI
Eligibility Criteria
Inclusion Criteria:
- Age > 50 years
- Documented symptomatic moderate or greater aortic stenosis or severe aortic insufficiency
- Aortic annulus > 19 mm
- Written informed consent of the patients.
Exclusion Criteria:
- Concomitant intervention of the aortic root, ascending aorta or aortic arch
- Concomitant valve surgery
- Emergency surgery for any reason
- Neurological events (i.e. stroke, TIA) within the previous 6 months
- Coagulation disorders (including thrombocytopenia < 100.000/ml)
- Porcelain aorta/severe calcification of the ascending aorta
- Active endocarditis or other active systemic infections
- Participating in another trial that may influence the outcome of this trial
- Pregnancy
- Dual antiplatelet therapy
- Previous cardiac surgery (excluding percutaneous procedures)
- Contraindication for MRI- examinations
Sites / Locations
- Deutsches Herzzentrum Muenchen, Department of Cardiovascular SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TriRec
Aortic valve replacement
Arm Description
Trileaflet Reconstruction of the Aortic Valve
Biological prosthesis, Device: Edwards Perimount
Outcomes
Primary Outcome Measures
Flow velocity in the ascending aorta (m/s)
Flow velocity in meters/ second in the ascending aorta in patients receiving either TriRec or biological prosthetic valve replacement measured by 4D- Flow- MRI.
Secondary Outcome Measures
Flow vortices
Flow vortices: defined as rotating particles around a point within the vessel with the rotational direction diverting > 90° from the physiological flow direction.
Flow helicality
Blood revolving around an axis parallel to the main blood flow generating a corkscrew like figure
Systolic eccentricity
Localization of the main blood flow vector (central, little, severe eccentricity).
Flow patterns in the left ventricular outflow tract.
Flow patterns in the left ventricular outflow tract.
Effective orifice area (4D-Flow-MRI)
Effective orifice area (cm2) of the reconstructed or replaced valve (4D- Flow- MRI)
Effective orifice area (TTE)
Effective orifice area (cm2) of the reconstructed or replaced valve (transthoracic echocardiography (TTE)
Peak- and mean pressure gradients (mmHg, TTE)
Peak- and mean pressure gradients (mmHg, TTE)
Left- ventricular diameters (mm, TTE)
Left- ventricular diameters (mm, TTE)
Left- ventricular ejection fraction (%, TTE)
Left- ventricular ejection fraction (%, TTE)
Quantification of aortic regurgitation (MRI)
Quantification of aortic regurgitation (MRI)
Quantification of aortic regurgitation (TTE)
Quantification of aortic regurgitation (TTE)
Full Information
NCT ID
NCT04223713
First Posted
November 29, 2019
Last Updated
March 2, 2021
Sponsor
Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT04223713
Brief Title
4D- Flow- MRI After Aortic Valve Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This randomized controlled trial was designed to analyze flow patterns in the ascending aorta with MRI after either Trileaflet reconstruction of the aortic valve with autologous pericardium (TriRec) or surgical valve replacement with biological prosthesis. The hypothesis is that after TriRec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease
Keywords
aortic stenosis, aortic regurgitation, Trileaflet reconstruction of the aortic valve, Biological aortic valve prosthesis, aortic flow patterns, MRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TriRec
Arm Type
Experimental
Arm Description
Trileaflet Reconstruction of the Aortic Valve
Arm Title
Aortic valve replacement
Arm Type
Experimental
Arm Description
Biological prosthesis, Device: Edwards Perimount
Intervention Type
Procedure
Intervention Name(s)
TriRec
Intervention Description
Trileaflet Reconstruction of the Aortic Valve
Intervention Type
Procedure
Intervention Name(s)
Aortic valve replacement
Intervention Description
Biological Prosthesis, Device: Edwards Perimount
Primary Outcome Measure Information:
Title
Flow velocity in the ascending aorta (m/s)
Description
Flow velocity in meters/ second in the ascending aorta in patients receiving either TriRec or biological prosthetic valve replacement measured by 4D- Flow- MRI.
Time Frame
Day 4-7 post surgery
Secondary Outcome Measure Information:
Title
Flow vortices
Description
Flow vortices: defined as rotating particles around a point within the vessel with the rotational direction diverting > 90° from the physiological flow direction.
Time Frame
Day 4-7 post surgery
Title
Flow helicality
Description
Blood revolving around an axis parallel to the main blood flow generating a corkscrew like figure
Time Frame
Day 4-7 post surgery
Title
Systolic eccentricity
Description
Localization of the main blood flow vector (central, little, severe eccentricity).
Time Frame
Day 4-7 post surgery
Title
Flow patterns in the left ventricular outflow tract.
Description
Flow patterns in the left ventricular outflow tract.
Time Frame
Day 4-7 post surgery
Title
Effective orifice area (4D-Flow-MRI)
Description
Effective orifice area (cm2) of the reconstructed or replaced valve (4D- Flow- MRI)
Time Frame
Day 4-7 post surgery
Title
Effective orifice area (TTE)
Description
Effective orifice area (cm2) of the reconstructed or replaced valve (transthoracic echocardiography (TTE)
Time Frame
Day 4-7 post surgery
Title
Peak- and mean pressure gradients (mmHg, TTE)
Description
Peak- and mean pressure gradients (mmHg, TTE)
Time Frame
Day 4-7 post surgery
Title
Left- ventricular diameters (mm, TTE)
Description
Left- ventricular diameters (mm, TTE)
Time Frame
Day 4-7 post surgery
Title
Left- ventricular ejection fraction (%, TTE)
Description
Left- ventricular ejection fraction (%, TTE)
Time Frame
Day 4-7 post surgery
Title
Quantification of aortic regurgitation (MRI)
Description
Quantification of aortic regurgitation (MRI)
Time Frame
Day 4-7 post surgery
Title
Quantification of aortic regurgitation (TTE)
Description
Quantification of aortic regurgitation (TTE)
Time Frame
Day 4-7 post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 50 years
Documented symptomatic moderate or greater aortic stenosis or severe aortic insufficiency
Aortic annulus > 19 mm
Written informed consent of the patients.
Exclusion Criteria:
Concomitant intervention of the aortic root, ascending aorta or aortic arch
Concomitant valve surgery
Emergency surgery for any reason
Neurological events (i.e. stroke, TIA) within the previous 6 months
Coagulation disorders (including thrombocytopenia < 100.000/ml)
Porcelain aorta/severe calcification of the ascending aorta
Active endocarditis or other active systemic infections
Participating in another trial that may influence the outcome of this trial
Pregnancy
Dual antiplatelet therapy
Previous cardiac surgery (excluding percutaneous procedures)
Contraindication for MRI- examinations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anatol Prinzing, MD
Phone
+49891218
Ext
2777
Email
prinzing@dhm.mhn.de
Facility Information:
Facility Name
Deutsches Herzzentrum Muenchen, Department of Cardiovascular Surgery
City
Munich
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anatol Prinzing, MD
12. IPD Sharing Statement
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4D- Flow- MRI After Aortic Valve Surgery
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