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Search / Trial NCT04816851

Aortic Valve Leaflets Reconstruction (Ozaki Procedure) in Aortic Valve Diseases

Launched by ASSIUT UNIVERSITY · Mar 23, 2021

Trial Information

Current as of May 30, 2025

Completed

Keywords

ClinConnect Summary

Heart valve disease signifies a severe growing public health problem in developing countries, with aortic valve stenosis being the most common issue. Heart valve disease is commonly initiated by atherosclerotic degenerative processes, congenital anomalies, or rheumatic process. Aortic valve replacement is the gold standard in the treatment of patients with severe aortic stenosis and aortic regurgitation. Mechanical valves are favoured in younger patients (\<60 years) owing to longer life-time, whereas biological valves are used for elderly patients in order to evade oral anticoagulation.

O...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Subject with AV disease.
  • Documented symptomatic moderate or greater aortic stenosis
  • small aortic annulus patients
  • A symptomatic aortic insufficiency patient with left ventricular dysfunction or significant left ventricular dilatation.
  • Patients with aortic regurgitation caused by: a dilated aortic annulus, conjoined cusp prolapse in bicuspid aortic valves (BAV), single cusp prolapse in tricuspid aortic valve (especially in paediatric population), and aortic valve cusp perforation from endocarditis.
  • Concomitant intervention of the aortic root, Concomitant intervention of the aortic arch, Concomitant valve surgery and Concomitant intervention at congenital anomaly.
  • Exclusion Criteria:
  • Patients with previous aortic valve surgery.
  • missing informed consent
  • Participation in another clinical research.

About Assiut University

Assiut University, a prominent academic institution located in Egypt, is dedicated to advancing medical research and clinical trials that enhance healthcare outcomes. With a strong emphasis on innovation and collaboration, the university engages in a wide array of clinical studies across various disciplines, aiming to contribute valuable insights into disease prevention, diagnosis, and treatment. Assiut University's commitment to ethical research practices and rigorous scientific methodology ensures the integrity and reliability of its clinical trials, ultimately benefiting both the local community and the global medical landscape.

Locations

Assiut, , Egypt

Patients applied

0 patients applied

Trial Officials

Ali Abd Elwahab, PHD

Principal Investigator

Assiut University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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