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NCT Number: NCT03836521

Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

The objective of this study is to evaluate the procedural and clinical outcomes of patients with bicuspid aortic valve stenosis undergoing transcatheter aortic valve replacement.

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Key information

Conditions

Bicuspid Aortic Valve Aortic Valve Disease 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

Age range

19 year–129 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Sung-Han Yoon, M.D.

CONTACT

[email protected]

310-423-7426

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age≥18 years.
  • Severe aortic stenosis with bicuspid anatomy.
  • NYHA≥2 and/or syncope and/or angina.
  • Patient judged by the Heart Team as indicated for TAVR.

Exclusion criteria

  • Age <18 years
  • Asymptomatic patients
  • Pure aortic regurgitation.

Treatment and study plan

Transcatheter Aortic Valve Replacement

Device

Primary outcomes

  1. Death

    Time frame: 1 month

    Death from any cause

  2. Death

    Time frame: 1 year

    Death from any cause

  3. Death

    Time frame: 2 years

    Death from any cause

  4. Death

    Time frame: 3 years

    Death from any cause

  5. Death

    Time frame: 4 years

    Death from any cause

  6. Death

    Time frame: 5 years

    Death from any cause

Secondary outcomes

  1. Death from cardiac cause

    Time frame: 1 month

    Death from cardiac cause

  2. Death from cardiac cause

    Time frame: 1 year

    Death from cardiac cause

  3. Death from cardiac cause

    Time frame: 2 years

    Death from cardiac cause

  4. Death from cardiac cause

    Time frame: 3 years

    Death from cardiac cause

  5. Death from cardiac cause

    Time frame: 4 years

    Death from cardiac cause

  6. Death from cardiac cause

    Time frame: 5 years

    Death from cardiac cause

  7. Stroke

    Time frame: 1 month

    disabling and non-disabling stroke

  8. Stroke

    Time frame: 1 year

    disabling and non-disabling stroke

  9. Stroke

    Time frame: 2 years

    disabling and non-disabling stroke

  10. Stroke

    Time frame: 3 years

    disabling and non-disabling stroke

  11. Stroke

    Time frame: 4 years

    disabling and non-disabling stroke

  12. Stroke

    Time frame: 5 years

    disabling and non-disabling stroke

  13. Repeat hospitalization

    Time frame: 1 month

    Number of hospitalizations

  14. Repeat hospitalization

    Time frame: 1 year

    Number of hospitalizations

  15. Repeat hospitalization

    Time frame: 2 years

    Number of hospitalizations

  16. Repeat hospitalization

    Time frame: 3 years

    Number of hospitalizations

  17. Repeat hospitalization

    Time frame: 4 years

    Number of hospitalizations

  18. Repeat hospitalization

    Time frame: 5 years

    Number of hospitalizations

  19. Bleeding

    Time frame: 1 month

    Life-threatening or major bleeding rate

  20. Bleeding

    Time frame: 1 year

    Life-threatening or major bleeding rate

  21. Bleeding

    Time frame: 2 years

    Life-threatening or major bleeding rate

  22. Bleeding

    Time frame: 3 years

    Life-threatening or major bleeding rate

  23. Bleeding

    Time frame: 4 years

    Life-threatening or major bleeding rate

  24. Bleeding

    Time frame: 5 years

    Life-threatening or major bleeding rate

  25. Vascular complication

    Time frame: 1 month

    Major vascular complication

  26. Vascular complication

    Time frame: 1 year

    Major vascular complication

  27. Vascular complication

    Time frame: 2 years

    Major vascular complication

  28. Vascular complication

    Time frame: 3 years

    Major vascular complication

  29. Vascular complication

    Time frame: 4 years

    Major vascular complication

  30. Vascular complication

    Time frame: 5 years

    Major vascular complication

  31. Acute kidney injury (stage 2 or 3)

    Time frame: 1 month

  32. Acute kidney injury (stage 2 or 3)

    Time frame: 1 year

  33. Acute kidney injury (stage 2 or 3)

    Time frame: 2 years

  34. Acute kidney injury (stage 2 or 3)

    Time frame: 3 years

  35. Acute kidney injury (stage 2 or 3)

    Time frame: 4 years

  36. Acute kidney injury (stage 2 or 3)

    Time frame: 5 years

  37. Prosthetic regurgitation by Doppler echocardiography

    Time frame: at discharge

  38. Prosthetic regurgitation by Doppler echocardiography

    Time frame: 1 month

  39. Prosthetic regurgitation by Doppler echocardiography

    Time frame: 1 year

  40. Prosthetic regurgitation by Doppler echocardiography

    Time frame: 2 years

  41. Prosthetic regurgitation by Doppler echocardiography

    Time frame: 3 years

  42. Prosthetic regurgitation by Doppler echocardiography

    Time frame: 4 years

  43. Prosthetic regurgitation by Doppler echocardiography

    Time frame: 5 years

  44. Mean aortic valve gradient by Doppler echocardiography

    Time frame: 1 month

  45. Mean aortic valve gradient by Doppler echocardiography

    Time frame: 1 year

  46. Mean aortic valve gradient by Doppler echocardiography

    Time frame: 2 years

  47. Mean aortic valve gradient by Doppler echocardiography

    Time frame: 3 years

  48. Mean aortic valve gradient by Doppler echocardiography

    Time frame: 4 years

  49. Mean aortic valve gradient by Doppler echocardiography

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Sung-Han Yoon, M.D.

CONTACT

[email protected]

3104237426

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
Feb 11, 2019
Registry last updated
Feb 11, 2019

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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