4D- Flow- MRI After Aortic Valve Surgery

Sponsor

Deutsches Herzzentrum Muenchen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04223713

Collaborator

(none)

Enrollment

Location

Arms

18.6

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease	Procedure: TriRec Procedure: Aortic valve replacement	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 14, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TriRec Trileaflet Reconstruction of the Aortic Valve	Procedure: TriRec Trileaflet Reconstruction of the Aortic Valve
Experimental: Aortic valve replacement Biological prosthesis, Device: Edwards Perimount	Procedure: Aortic valve replacement Biological Prosthesis, Device: Edwards Perimount

Arm

Intervention/Treatment

Experimental: TriRec

Trileaflet Reconstruction of the Aortic Valve

Procedure: TriRec

Trileaflet Reconstruction of the Aortic Valve

Experimental: Aortic valve replacement

Biological prosthesis, Device: Edwards Perimount

Procedure: Aortic valve replacement

Biological Prosthesis, Device: Edwards Perimount

Outcome Measures

Primary Outcome Measures

Flow velocity in the ascending aorta (m/s) [Day 4-7 post surgery]
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 [Day 4-7 post surgery]
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 [Day 4-7 post surgery]
Blood revolving around an axis parallel to the main blood flow generating a corkscrew like figure
Systolic eccentricity [Day 4-7 post surgery]
Localization of the main blood flow vector (central, little, severe eccentricity).
Flow patterns in the left ventricular outflow tract. [Day 4-7 post surgery]
Flow patterns in the left ventricular outflow tract.
Effective orifice area (4D-Flow-MRI) [Day 4-7 post surgery]
Effective orifice area (cm2) of the reconstructed or replaced valve (4D- Flow- MRI)
Effective orifice area (TTE) [Day 4-7 post surgery]
Effective orifice area (cm2) of the reconstructed or replaced valve (transthoracic echocardiography (TTE)
Peak- and mean pressure gradients (mmHg, TTE) [Day 4-7 post surgery]
Peak- and mean pressure gradients (mmHg, TTE)
Left- ventricular diameters (mm, TTE) [Day 4-7 post surgery]
Left- ventricular diameters (mm, TTE)
Left- ventricular ejection fraction (%, TTE) [Day 4-7 post surgery]
Left- ventricular ejection fraction (%, TTE)
Quantification of aortic regurgitation (MRI) [Day 4-7 post surgery]
Quantification of aortic regurgitation (MRI)
Quantification of aortic regurgitation (TTE) [Day 4-7 post surgery]
Quantification of aortic regurgitation (TTE)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.