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Small Aortic Annulus - a New Solution to the Old Problem

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ClinicalTrials.gov Identifier: NCT03258333
Recruitment Status : Active, not recruiting
First Posted : August 23, 2017
Last Update Posted : August 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mikulyak Artur, The Federal Centre of Cardiovascular Surgery, Russia

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)

Condition or disease Intervention/treatment
Aortic Valve Replacement Procedure: aortic valve replacement

Detailed 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)

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Small Aortic Annulus - a New Solution to the Old Problem
Actual Study Start Date : February 18, 2017
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium

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




Primary Outcome Measures :
  1. Indexed effective orifice area, cm²/m² [ Time Frame: 12 months after surgery ]
    Assessment of aortic valve dimension


Secondary Outcome Measures :
  1. prosthesis-patient mismatch (PPM) [ Time Frame: 12 months after surgery ]
    Indicator of the effectiveness of aortic valve replacement

  2. Peak pressure gradient, mm.Hg [ Time Frame: 12 months after surgery ]
    Indicator of the effectiveness of aortic valve replacement

  3. Mean pressure gradient, mm.Hg [ Time Frame: 12 months after surgery ]
    Indicator of the effectiveness of aortic valve replacement

  4. Effective orifice area, EOA, cm² [ Time Frame: 12 months after surgery ]
    Assessment of aortic valve dimension


Other Outcome Measures:
  1. Age (years) [ Time Frame: 12 months after surgery ]
    Description and comparison of groups patients

  2. Body mass index, kg/m² [ Time Frame: 12 months after surgery ]
    Description and comparison of groups patients

  3. Body surface area, m² [ Time Frame: 12 months after surgery ]
    Description and comparison of groups patients

  4. Aortic annulus diameter, mm [ Time Frame: 12 months after surgery ]
    Description and comparison of groups patients

  5. Indexed aortic annulus diameter, mm/m² [ Time Frame: 12 months after surgery ]
    Description and comparison of groups patients

  6. Myocardial mass index, g/m² [ Time Frame: 12 months after surgery ]
    Assessment of reverse remodeling of the left ventricle



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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with severe degenerative aortic stenosis and small aortic annulus (<21 mm) were enrolled in this study
Criteria

Inclusion Criteria:

  • severe degenerative aortic valve stenosis

Exclusion Criteria:

  • redo operation, infective endocarditis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258333


Locations
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Russian Federation
FederalCCS
Penza, Russian Federation, 440071
Sponsors and Collaborators
The Federal Centre of Cardiovascular Surgery, Russia
Publications of Results:

Other Publications:
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Responsible Party: Mikulyak Artur, Principal Investigator, Cardiovascular surgeon, The Federal Centre of Cardiovascular Surgery, Russia
ClinicalTrials.gov Identifier: NCT03258333    
Other Study ID Numbers: FederalCCS002
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 23, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mikulyak Artur, The Federal Centre of Cardiovascular Surgery, Russia:
aortic stenosis, aortic valve replacement, pericardium