4D- Flow- MRI After Aortic Valve Surgery

Not Applicable

• Conditions: Aortic Valve Disease
• Interventions: Procedure: Aortic valve replacement; Procedure: TriRec

• Registration Number: NCT04223713
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Study Timeline

• Study First Submitted: 2019-11-29
• Study First Submitted QC: 2020-01-08
• Study First Posted: 2020-01-10
• Study Start: 2020-01-14
• Status Verified: 2021-01
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-04
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aortic valve replacement	Aortic valve replacement	Biological prosthesis, Device: Edwards Perimount
TriRec	TriRec	Trileaflet Reconstruction of the Aortic Valve

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Peak- and mean pressure gradients (mmHg, TTE)	Day 4-7 post surgery	Peak- and mean pressure gradients (mmHg, TTE)
Flow helicality	Day 4-7 post surgery	Blood revolving around an axis parallel to the main blood flow generating a corkscrew like figure
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.
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)
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)

Trial Locations

Locations (1)

Deutsches Herzzentrum Muenchen, Department of Cardiovascular Surgery; 🇩🇪 Munich, Germany