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Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis (SA-AVR)

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ClinicalTrials.gov Identifier: NCT03976817
Recruitment Status : Completed
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

Brief Summary:
Surgical valve replacement is commonly performed in patients with severe aortic valve disease. In small aortic annulus, implantation of bioprosthetic valves can be associated with limited functional capacity. To avoid this condition, we changed our surgical technique to implant a larger bioprosthesis. Briefly, the prosthesis is sutured to the aortic annulus along the left and right coronary sinuses, and in a supraannular position along the noncoronary sinus, therefore allowing us to insert a prosthetic valve with a one-size larger diameter than the native aortic annulus.

Condition or disease Intervention/treatment
Aortic Valve Disease Prosthesis; Cardiac, Heart, Functional Disturbance as Result Procedure: aortic valve replacement

Detailed Description:
Surgical aortic valve replacement (AVR) is recommended for severe aortic valve disease. Bioprosthesis remains the substitute of choice for elderly patients. However, it may be associated with patient-prosthesis mismatch particularly for patients with small aortic annulus. Moreover, "valve-in-valve" transcatheter aortic valve replacement (TAVR) has become a suitable therapeutic option for bioprosthesis structural degeneration, especially in patients with high surgical risk. It is therefore of great importance to implant the widest bioprosthesis as possible at the first AVR. The investigators report a surgical technique allowing the implantation of a larger bioprosthesis in patients with small aortic annulus: the supra-annular aortic valve replacement (SA-AVR) above the aortic annulus. The investigators analyzed the postoperative outcomes of the SA-AVR technique using the Perimount Magna Ease (Carpentier-Edwards, Irvine, California) bioprosthesis.

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Study Type : Observational
Actual Enrollment : 117 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Supra-annular Aortic Valve Replacement: Surgical Techniques and Early Outcomes
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : April 1, 2019

Group/Cohort Intervention/treatment
SA-AVR group
Patients who underwent the supra-annular aortic valve replacement (SA-AVR) technique in our institution between December 2010 and December 2017 were retrospectively reviewed.
Procedure: aortic valve replacement
After median sternotomy, cardiopulmonary bypass (CPB) was established between the ascending aorta and the right atrium. The aorta was cross-clamped and a high potassium warm cardioplegia was infused and repeated every 15 minutes. The aortotomy was made above the sinuses and the aortic valve was removed. The prosthesis was chosen one size larger than the maximal sizer that could be inserted, which was also used to determine the appropriate height for insertion of the sutures along the wall of the non-coronary sinus.




Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: Hospital discharge, an average 10 days ]

Secondary Outcome Measures :
  1. Functional status [ Time Frame: 1 year after the surgery ]
    New York Heart Association functional class (from I to IV)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent aortic valve replacement in our institution
Criteria

Inclusion Criteria:

  • patients older than 18 years who underwent a suprannular implantation of the Carpentier Edwards Magna Ease bioprosthetic valve between January 2010 and December 2017 in our institution, whatever the aetiology of the aortic valve disease.

Exclusion Criteria:

  • patients younger than 18 years, patients who received a different bioprosthesis valve in the aortic position, patients who were lost of follow-up.

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): NCT03976817


Locations
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France
Hopital Marie Lannelongue
Le Plessis-Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue
Investigators
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Study Chair: Elie Fadel, MD PhD Marie Lannelongue Hospital

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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT03976817     History of Changes
Other Study ID Numbers: TPS 59185
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Centre Chirurgical Marie Lannelongue:
bioprosthesis
surgery
supra-annular

Additional relevant MeSH terms:
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Pathologic Processes