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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03258333
Other study ID # FederalCCS002
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 23, 2017
Last updated August 20, 2017
Start date February 18, 2017
Est. completion date July 1, 2022

Study information

Verified date August 2017
Source The Federal Centre of Cardiovascular Surgery, Russia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this prospective single-center study included 60 patients with a severe degenerative aortic stenosis and small aortic annulus (<21 mm) who underwent standard AVR with stented bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium (Ozaki procedure) (group 2, n=30)


Description:

Aortic valve replacement (AVR) in patients with a small aortic annulus is a challenging problem. Implantation of a small aortic valve sometimes leads to high residual gradients, despite a normally functioning prosthesis. Patients with a small aortic annulus, especially those with a large body surface area, are at higher risk of prosthesis-patient mismatch, which is associated with worse clinical outcomes and decreased survival. The purpose of this study was to compare the hemodynamic performance among the 2 management strategies (standard AVR with stented bioprosthesis and Ozaki procedure) in the context of a small aortic annulus (<21 mm)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date July 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years to 90 Years
Eligibility Inclusion Criteria:

- severe degenerative aortic valve stenosis

Exclusion Criteria:

- redo operation, infective endocarditis

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
aortic valve replacement
Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium

Locations

Country Name City State
Russian Federation FederalCCS Penza

Sponsors (1)

Lead Sponsor Collaborator
The Federal Centre of Cardiovascular Surgery, Russia

Country where clinical trial is conducted

Russian Federation, 

References & Publications (7)

Borger MA, Nette AF, Maganti M, Feindel CM. Carpentier-Edwards Perimount Magna valve versus Medtronic Hancock II: a matched hemodynamic comparison. Ann Thorac Surg. 2007 Jun;83(6):2054-8. — View Citation

Gerosa G, Tarzia V, Rizzoli G, Bottio T. Small aortic annulus: the hydrodynamic performances of 5 commercially available tissue valves. J Thorac Cardiovasc Surg. 2006 May;131(5):1058-64. — View Citation

Ghoneim A, Bouhout I, Demers P, Mazine A, Francispillai M, El-Hamamsy I, Carrier M, Lamarche Y, Bouchard D. Management of small aortic annulus in the era of sutureless valves: A comparative study among different biological options. J Thorac Cardiovasc Sur — View Citation

Minardi G, Pergolini A, Zampi G, Pulignano G, Pero G, Sbaraglia F, Pino PG, Cioffi G, Musumeci F. St. Jude Trifecta versus Carpentier-Edwards Perimount Magna valves for the treatment of aortic stenosis: comparison of early Doppler-echocardiography and hem — View Citation

Morita S. Aortic valve replacement and prosthesis-patient mismatch in the era of trans-catheter aortic valve implantation. Gen Thorac Cardiovasc Surg. 2016 Aug;64(8):435-40. doi: 10.1007/s11748-016-0657-9. Epub 2016 May 27. Review. — View Citation

Ozaki S, Kawase I, Yamashita H, Uchida S, Nozawa Y, Matsuyama T, Takatoh M, Hagiwara S. Aortic valve reconstruction using self-developed aortic valve plasty system in aortic valve disease. Interact Cardiovasc Thorac Surg. 2011 Apr;12(4):550-3. doi: 10.151 — View Citation

Ozaki S, Kawase I, Yamashita H, Uchida S, Takatoh M, Hagiwara S, Kiyohara N. Aortic Valve Reconstruction Using Autologous Pericardium for Aortic Stenosis. Circ J. 2015;79(7):1504-10. doi: 10.1253/circj.CJ-14-1092. Epub 2015 Mar 30. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Age (years) Description and comparison of groups patients 12 months after surgery
Other Body mass index, kg/m² Description and comparison of groups patients 12 months after surgery
Other Body surface area, m² Description and comparison of groups patients 12 months after surgery
Other Aortic annulus diameter, mm Description and comparison of groups patients 12 months after surgery
Other Indexed aortic annulus diameter, mm/m² Description and comparison of groups patients 12 months after surgery
Other Myocardial mass index, g/m² Assessment of reverse remodeling of the left ventricle 12 months after surgery
Primary Indexed effective orifice area, cm²/m² Assessment of aortic valve dimension 12 months after surgery
Secondary prosthesis-patient mismatch (PPM) Indicator of the effectiveness of aortic valve replacement 12 months after surgery
Secondary Peak pressure gradient, mm.Hg Indicator of the effectiveness of aortic valve replacement 12 months after surgery
Secondary Mean pressure gradient, mm.Hg Indicator of the effectiveness of aortic valve replacement 12 months after surgery
Secondary Effective orifice area, EOA, cm² Assessment of aortic valve dimension 12 months after surgery
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