Small Aortic Annulus - a New Solution to the Old Problem

Aortic Valve Replacement Clinical Trial

Official title:

Small Aortic Annulus - a New Solution to the Old Problem

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03258333
• Other study ID #: FederalCCS002
• 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
• 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

Related Conditions & MeSH terms

• Aortic Valve Replacement

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