Clinical trial NCT04223713: 4D- Flow- MRI After Aortic Valve Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Disease
Keywords: aortic stenosis
aortic regurgitation
Trileaflet reconstruction of the aortic valve
Biological aortic valve prosthesis
aortic flow patterns
MRI
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Flow velocity in the ascending aorta (m/s)
timeFrame: Day 4-7 post surgery
Secondary outcomes:
measure: Flow vortices
timeFrame: Day 4-7 post surgery
measure: Flow helicality
timeFrame: Day 4-7 post surgery
measure: Systolic eccentricity
timeFrame: Day 4-7 post surgery
measure: Flow patterns in the left ventricular outflow tract.
timeFrame: Day 4-7 post surgery
measure: Effective orifice area (4D-Flow-MRI)
timeFrame: Day 4-7 post surgery
measure: Effective orifice area (TTE)
timeFrame: Day 4-7 post surgery
measure: Peak- and mean pressure gradients (mmHg, TTE)
timeFrame: Day 4-7 post surgery
measure: Left- ventricular diameters (mm, TTE)
timeFrame: Day 4-7 post surgery
measure: Left- ventricular ejection fraction (%, TTE)
timeFrame: Day 4-7 post surgery
measure: Quantification of aortic regurgitation (MRI)
timeFrame: Day 4-7 post surgery
measure: Quantification of aortic regurgitation (TTE)
timeFrame: Day 4-7 post surgery
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen, Department of Cardiovascular Surgery
Study officials:
References: