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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
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Vienna, Østerrike, 1090
- Rekruttering
- Medical University of Vienna
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Ta kontakt med:
- Claus Rath, MD
- Telefonnummer: 0043-1-40400-69660
- E-post: claus.rath@meduniwien.ac.at
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Ta kontakt med:
- Alfred Kocher, MD
- Telefonnummer: 0043-1-40400-69660
- E-post: alfred.kocher@meduniwien.ac.at
-
Hovedetterforsker:
- Alfred Kocher, MD
-
Underetterforsker:
- Claus Rath, MD
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Underetterforsker:
- Martin Andreas, MD
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Underetterforsker:
- Dominik Wiedemann, MD
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Underetterforsker:
- Guenther Laufer, MD
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Underetterforsker:
- Christian Loewe, MD
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Underetterforsker:
- Raphael Rosenhek, MD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: "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. |
|
Annen: "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.
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Comparison of maximum and minimum velocity under patient specific conditions
Tidsramme: between 6 months and 4 years after aortic valve replacement
|
between 6 months and 4 years after aortic valve replacement
|
|
Comparison of the effective orifice area under patient specific conditions
Tidsramme: between 6 months and 4 years after aortic valve replacement
|
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
Tidsramme: between 6 months and 4 years after aortic valve replacement
|
between 6 months and 4 years after aortic valve replacement
|
|
Comparison of the pressure drop under patient specific conditions
Tidsramme: between 6 months and 4 years after aortic valve replacement
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between 6 months and 4 years after aortic valve replacement
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient-specific, computer simulated pressure gradients compared to echocardiographically obtained pressure gradients.
Tidsramme: between 6 months and 4 years after aortic valve replacement
|
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
|
|
Patient-specific, computer simulated peak velocity compared to echocardiographically obtained peak velocity.
Tidsramme: between 6 months and 4 years after aortic valve replacement
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Alfred Kocher, MD, Division of Cardiac Surgery, Department of Surgery, Medical University of Vienna
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1790/2013-1
Legemiddel- og utstyrsinformasjon, studiedokumenter
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