4D- Flow- MRI After Aortic Valve Surgery

Aortic Valve Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04223713
• Other study ID #: 77/19-S
• Status: Recruiting
• Phase: N/A
• Start date: January 14, 2020
• Est. completion date: August 2021

Study information

• Verified date: January 2021
• Source: Deutsches Herzzentrum Muenchen
• Contact: Anatol Prinzing, MD
• Phone: +49891218
• Email: prinzing[@]dhm.mhn.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disease

Intervention

Procedure:
• TriRec
Trileaflet Reconstruction of the Aortic Valve
• Aortic valve replacement
Biological Prosthesis, Device: Edwards Perimount

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum Muenchen, Department of Cardiovascular Surgery	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 4-7 post surgery
Secondary	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.	Day 4-7 post surgery
Secondary	Flow helicality	Blood revolving around an axis parallel to the main blood flow generating a corkscrew like figure	Day 4-7 post surgery
Secondary	Systolic eccentricity	Localization of the main blood flow vector (central, little, severe eccentricity).	Day 4-7 post surgery
Secondary	Flow patterns in the left ventricular outflow tract.	Flow patterns in the left ventricular outflow tract.	Day 4-7 post surgery
Secondary	Effective orifice area (4D-Flow-MRI)	Effective orifice area (cm2) of the reconstructed or replaced valve (4D- Flow- MRI)	Day 4-7 post surgery
Secondary	Effective orifice area (TTE)	Effective orifice area (cm2) of the reconstructed or replaced valve (transthoracic echocardiography (TTE)	Day 4-7 post surgery
Secondary	Peak- and mean pressure gradients (mmHg, TTE)	Peak- and mean pressure gradients (mmHg, TTE)	Day 4-7 post surgery
Secondary	Left- ventricular diameters (mm, TTE)	Left- ventricular diameters (mm, TTE)	Day 4-7 post surgery
Secondary	Left- ventricular ejection fraction (%, TTE)	Left- ventricular ejection fraction (%, TTE)	Day 4-7 post surgery
Secondary	Quantification of aortic regurgitation (MRI)	Quantification of aortic regurgitation (MRI)	Day 4-7 post surgery
Secondary	Quantification of aortic regurgitation (TTE)	Quantification of aortic regurgitation (TTE)	Day 4-7 post surgery