NCT03258333

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

4.9 years

First QC Date

July 23, 2017

Last Update Submit

August 20, 2017

Conditions

Aortic Valve Replacement

Keywords

aortic stenosis, aortic valve replacement, pericardium

Outcome Measures

Primary Outcomes (1)

  • Indexed effective orifice area, cm²/m²

    Assessment of aortic valve dimension

    12 months after surgery

Secondary Outcomes (4)

  • prosthesis-patient mismatch (PPM)

    12 months after surgery

  • Peak pressure gradient, mm.Hg

    12 months after surgery

  • Mean pressure gradient, mm.Hg

    12 months after surgery

  • Effective orifice area, EOA, cm²

    12 months after surgery

Other Outcomes (6)

  • Age (years)

    12 months after surgery

  • Body mass index, kg/m²

    12 months after surgery

  • Body surface area, m²

    12 months after surgery

  • +3 more other outcomes

Study Arms (2)

Stented bioprosthesis

Standard aortic valve replacement with stented bioprosthesis. Surgery is performed through median sternotomy, aortic and right or bicaval venous cannulation, normothermic perfusion, antegrade cardioplegia with use cardioplegic solution Custodiol. A transverse aortotomy was performed 1 to 2 cm above the right coronary artery. The aortic annulus was thoroughly débrided of calcium. Valve sizing was performed with standard manufacturers' sizers, with selection of the size that would comfortably fit within the aortic annulus. A noneverting suture technique was used in all patients with interrupted horizontal mattress 2-0 braided sutures placed around the aortic annulus, with the pledgets on the ventricular aspect.

Procedure: aortic valve replacement

Ozaki procedure

Aortic valve reconstruction using autologus pericardium (Ozaki procedure). The autologous pericardium is harvested after routine median sternotomy. Harvested pericardium is then treated with a 0.6% glutaraldehyde solution for 10 min and then rinsed 3 times with sterilized saline each time for 6 min. After resection of the diseased aortic valve cusps, the distance between each commissure is measured using a self-developed sizing instrument. Glutaraldehyde-treated autologous pericardium is trimmed with a self-developed template corresponding to the measured value. The annular margin of the pericardial leaflet is then running-sutured to each annulus with 3-0 monofilament sutures. Commissural coaptation is secured with additional 4-0 monofilament sutures. The coaptation of the 3 cusps is then checked with negative pressure on the left ventricular vent.

Procedure: aortic valve replacement

Interventions

aortic valve replacementPROCEDURE

Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium

Ozaki procedureStented bioprosthesis

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with severe degenerative aortic stenosis and small aortic annulus (\<21 mm) were enrolled in this study

You may qualify if:

  • severe degenerative aortic valve stenosis

You may not qualify if:

  • redo operation, infective endocarditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FederalCCS

Penza, 440071, Russia

Location

Related Publications (7)

  • 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. doi: 10.1016/j.jtcvs.2005.12.034.

    PMID: 16678590BACKGROUND

  • 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.

    PMID: 25818901RESULT

  • 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: 10.1510/icvts.2010.253682. Epub 2011 Jan 27.

    PMID: 21273254RESULT

  • 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. doi: 10.1016/j.athoracsur.2007.02.062.

    PMID: 17532395RESULT

  • 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 Surg. 2016 Oct;152(4):1019-28. doi: 10.1016/j.jtcvs.2016.06.058. Epub 2016 Jul 28.

    PMID: 27641297RESULT

  • 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.

    PMID: 27234223RESULT

  • 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 hemodynamic performance. Monaldi Arch Chest Dis. 2013 Sep;80(3):126-32. doi: 10.4081/monaldi.2013.74.

    PMID: 24818319RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Cardiovascular surgeon

Study Record Dates

First Submitted

July 23, 2017

First Posted

August 23, 2017

Study Start

February 18, 2017

Primary Completion

January 1, 2022

Study Completion

July 1, 2022

Last Updated

August 23, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

Locations

RU(1)