Pilot Trial: Comparison of Flow Patterns
Pilot Trial: Comparison of Flow Patterns. Is There a Difference Between sewed-in and "Sutureless" Bioprosthetic Aortic Heart Valves?
The purpose of this study is to determine why sutureless aortic bioprostheses apparently offer better haemodynamic properties compared to sewed-in aortic bioprostheses in patients who underwent aortic valve replacement.
Our approach to address this question is the combination of clinical data with the application of specifically validated experimental and computer based analyses to compare the performance of these valves under patient-specific conditions.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Vienna, Austria, 1090
- Rekrutacyjny
- Medical University of Vienna
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Kontakt:
- Claus Rath, MD
- Numer telefonu: 0043-1-40400-69660
- E-mail: claus.rath@meduniwien.ac.at
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Kontakt:
- Alfred Kocher, MD
- Numer telefonu: 0043-1-40400-69660
- E-mail: alfred.kocher@meduniwien.ac.at
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Główny śledczy:
- Alfred Kocher, MD
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Pod-śledczy:
- Claus Rath, MD
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Pod-śledczy:
- Martin Andreas, MD
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Pod-śledczy:
- Dominik Wiedemann, MD
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Pod-śledczy:
- Guenther Laufer, MD
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Pod-śledczy:
- Christian Loewe, MD
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Pod-śledczy:
- Raphael Rosenhek, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Patient underwent open aortic valve replacement with either an Edwards Magna Ease or an Edwards Intuity valve
- Implanted valve size 23mm
- Surgical access via full sternotomy or hemisternotomy
- Intuity Valve System implanted by one of the clinical investigators of the TRITON trial (http://clinicaltrials.gov/show/NCT01445171) at the Medical University of Vienna
- Post-operative ejection fraction ≥50%
- Sinus-Rhythm
- Ability to understand and comply with study procedures
- Signed informed consent
Exclusion Criteria:
- Under 18 years of age
- Emergency surgery
- Pregnancy
- Previous aortic root replacement
- Previous aortic valve replacement
- Previous or concomitant root enlargement
- Previous or concomitant repair of the ascending aorta
- Paravalvular leakage
- Ectasia of the ascending aorta
- Previous or concomitant myomectomy
- Concomitant replacement or repair of valves other than aortic
- Usage of more than 3 sutures for implantation of the Intuity Valve System
- Heavily calcified aortic root
- Glomerular filtration rate (GFR) < 30 ml/min
- Inability to understand or comply with study procedures
- Known allergic reaction to iodinated, non-ionic contrast agents
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Nielosowe
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Inny: "Sutureless" valve
Patients who underwent aortic valve replacement with a "sutureless" aortic valve. An echocardiogram and a cardiac CT-scan will be conducted. |
ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs). In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves. |
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Inny: "Sewed-in" valve
Patients who underwent aortic valve replacement with a "sewed-in" aortic valve.
An echocardiogram and a cardiac CT-scan will be conducted.
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ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs). In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
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Comparison of maximum and minimum velocity under patient specific conditions
Ramy czasowe: between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
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Comparison of the effective orifice area under patient specific conditions
Ramy czasowe: between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
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Comparison of the percentage of turbulent flow under patient specific conditions
Ramy czasowe: between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
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Comparison of the pressure drop under patient specific conditions
Ramy czasowe: between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.
Ramy czasowe: between 6 months and 4 years after aortic valve replacement
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The first secondary outcome measure is the comparison of -pressure gradients as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified. If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics." |
between 6 months and 4 years after aortic valve replacement
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Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.
Ramy czasowe: between 6 months and 4 years after aortic valve replacement
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The second secondary outcome measure is the comparison of -peak velocity as computed by the model against the same data collected standardly with echocardiographic technique. Differences will be quantified. If positive (< 10%), this assessment would enhance the use of patient-specific models in clinics as a predictive tool for detailed haemodynamics." |
between 6 months and 4 years after aortic valve replacement
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Alfred Kocher, MD, Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1790/2013-1
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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