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Completed

NCT Number: NCT05836363

Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement

Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications.

There is no agreement regarding the opportunity for a "prophylactic" simultaneous aortic valve replacement in the case of mild or moderate aortic valve disease in the bicuspid valve, in patients with an indication for replacement of the ascending aorta due to an aneurysm involving its supra-coronary tract.

The aim of this study is to evaluate the long-term evolution of mild and moderate aortic valve disease in untreated bicuspid valve during supracoronary ascending aortic replacement surgery at our institution.

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Key information

Conditions

Bicuspid Aortic Valve Aneurysm Aneurysm, Ascending Aorta Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Diseases Aortic Valve Disease Ascending Aorta Aneurysm Bicuspid Aortic Valve Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Valve Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients;
  • Bicuspid aortic valve;
  • Presence of ascending aortic aneurysm in the supra-coronary tract treated with replacement using a prosthetic tube between 2002 and January 2020;
  • Untreated aortic valve disease of no more than moderate degree (<2+) at the time of ascending aorta surgery.

Exclusion criteria

  • Emergency/urgency procedures;
  • Presence of aneurysm extending to the aortic arch or aortic root, with indication for aortic root or aortic arch surgery;
  • Tricuspid aortic valve tricuspid;
  • Absence of aortic valve disease;
  • Presence of moderate-severe or severe aortic valve disease, with indication to a concomitant aortic valve replacement.

Treatment and study plan

Ascending aorta replacement

Procedure

The aneurysmatic ascending aorta tract is replaced with a tubular dacron prosthesis

Primary outcomes

  1. Aortic valve regurgitation

    Time frame: Through study completion, a minimum of 6 months

Sponsors and collaborators

Lead sponsor

Michele De Bonis

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 1, 2023
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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