4D- Flow- MRI After Aortic Valve Surgery

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Deutsches Herzzentrum Muenchen
Updated on 19 February 2024
stenosis
aortic valve stenosis
aortic valve replacement
aortic valve surgery
aortic stenosis
aortic valve disease

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.

Details
Condition Aortic Valve Disease
Age 50-100 years
Treatment TriRec, Aortic valve replacement
Clinical Study IdentifierNCT04223713
SponsorDeutsches Herzzentrum Muenchen
Last Modified on19 February 2024

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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