4D- Flow- MRI After Aortic Valve Surgery

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Recruiting
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30
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Deutsches Herzzentrum Muenchen

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Updated on 19 February 2024

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stenosis

aortic valve stenosis

aortic valve replacement

aortic valve surgery

aortic stenosis

aortic valve disease

Summary

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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.

Details

Condition	Aortic Valve Disease
Age	50years - 100years
Treatment	TriRec, Aortic valve replacement
Clinical Study Identifier	NCT04223713
Sponsor	Deutsches Herzzentrum Muenchen
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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

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4D- Flow- MRI After Aortic Valve Surgery