4D- Flow- MRI After Aortic Valve Surgery

German Heart Center Munich

Status: Unknown

Conditions: Aortic Valve Disease

Treatments: Procedure: Aortic valve replacement; Procedure: TriRec

Study type: Interventional

Funder types: Other

Identifiers

NCT04223713

77/19-S

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

TriRec

Experimental group

Description:

Trileaflet Reconstruction of the Aortic Valve

Treatment:

Procedure: TriRec

Aortic valve replacement

Experimental group

Description:

Biological prosthesis, Device: Edwards Perimount

Treatment:

Procedure: Aortic valve replacement