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

NCT03976817 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 117

Last updated 2019-06-06

No results posted yet for this study

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.

Conditions

  • Aortic Valve Disease
  • Prosthesis; Cardiac, Heart, Functional Disturbance as Result

Interventions

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.

Sponsors & Collaborators

  • Centre Chirurgical Marie Lannelongue

    lead OTHER

Principal Investigators

  • Elie Fadel, MD PhD · Marie Lannelongue Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2018-12-31
Completion
2019-04-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03976817 on ClinicalTrials.gov