Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-01-14
2021-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TriRec
Trileaflet Reconstruction of the Aortic Valve
TriRec
Trileaflet Reconstruction of the Aortic Valve
Aortic valve replacement
Biological prosthesis, Device: Edwards Perimount
Aortic valve replacement
Biological Prosthesis, Device: Edwards Perimount
Interventions
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TriRec
Trileaflet Reconstruction of the Aortic Valve
Aortic valve replacement
Biological Prosthesis, Device: Edwards Perimount
Eligibility Criteria
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Inclusion Criteria
* Documented symptomatic moderate or greater aortic stenosis or severe aortic insufficiency
* Aortic annulus \> 19 mm
* Written informed consent of the patients.
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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Deutsches Herzzentrum Muenchen
OTHER
Responsible Party
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Locations
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Deutsches Herzzentrum Muenchen, Department of Cardiovascular Surgery
Munich, , Germany
Countries
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Central Contacts
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Facility Contacts
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Anatol Prinzing, MD
Role: primary
Other Identifiers
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77/19-S
Identifier Type: -
Identifier Source: org_study_id
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