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Completed

NCT Number: NCT02394184

The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Bicuspid 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 Ventricular Outflow Obstruction

Sex eligibility

All sexes

Study type

Observational

Primary location

Asan Medical Center

Seoul, South Korea

About this study

This registry is a subgroup of Asian TAVR registry(NCT02308150) and Asian TAVR registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with bicuspid aortic valve stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
  • The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.

Treatment and study plan

Transcatheter aortic valve replacement

Procedure

Primary outcomes

  1. Death

    Time frame: 1 month

  2. Death

    Time frame: 6 months

  3. Death

    Time frame: 1 year

  4. Death

    Time frame: 2 years

  5. Death

    Time frame: 3 years

  6. Death

    Time frame: 4 years

  7. Death

    Time frame: 5 years

Secondary outcomes

  1. Death from cardiac cause

    Time frame: 1 month

  2. Death from cardiac cause

    Time frame: 6 months

  3. Death from cardiac cause

    Time frame: 1 year

  4. Death from cardiac cause

    Time frame: 2 years

  5. Death from cardiac cause

    Time frame: 3 years

  6. Death from cardiac cause

    Time frame: 4 years

  7. Death from cardiac cause

    Time frame: 5 years

  8. Stroke

    Time frame: 1 month

  9. Stroke

    Time frame: 6 months

  10. Stroke

    Time frame: 1 year

  11. Stroke

    Time frame: 2 years

  12. Stroke

    Time frame: 3 years

  13. Stroke

    Time frame: 4 years

  14. Stroke

    Time frame: 5 years

  15. Myocardial infarction

    Time frame: 1 month

  16. Myocardial infarction

    Time frame: 6 months

  17. Myocardial infarction

    Time frame: 1 year

  18. Myocardial infarction

    Time frame: 2 years

  19. Myocardial infarction

    Time frame: 3 years

  20. Myocardial infarction

    Time frame: 4 years

  21. Myocardial infarction

    Time frame: 5 years

  22. Repeat hospitalization

    Time frame: 1 month

  23. Repeat hospitalization

    Time frame: 6 months

  24. Repeat hospitalization

    Time frame: 1 year

  25. Repeat hospitalization

    Time frame: 2 years

  26. Repeat hospitalization

    Time frame: 3 years

  27. Repeat hospitalization

    Time frame: 4 years

  28. Repeat hospitalization

    Time frame: 5 years

  29. Acute kidney injury

    Time frame: 1 month

  30. Acute kidney injury

    Time frame: 6 months

  31. Acute kidney injury

    Time frame: 1 year

  32. Acute kidney injury

    Time frame: 2 years

  33. Acute kidney injury

    Time frame: 3 years

  34. Acute kidney injury

    Time frame: 4 years

  35. Acute kidney injury

    Time frame: 5 years

  36. Vascular complication

    Time frame: 1 month

  37. Vascular complication

    Time frame: 6 months

  38. Vascular complication

    Time frame: 1 year

  39. Vascular complication

    Time frame: 2 years

  40. Vascular complication

    Time frame: 3 years

  41. Vascular complication

    Time frame: 4 years

  42. Vascular complication

    Time frame: 5 years

  43. Bleeding events

    Time frame: 1 month

  44. Bleeding events

    Time frame: 6 months

  45. Bleeding events

    Time frame: 1 year

  46. Bleeding events

    Time frame: 2 years

  47. Bleeding events

    Time frame: 3 years

  48. Bleeding events

    Time frame: 4 years

  49. Bleeding events

    Time frame: 5 years

  50. Device success

    Time frame: 1 month

  51. Device success

    Time frame: 6 months

  52. Device success

    Time frame: 1 year

  53. Device success

    Time frame: 2 years

  54. Device success

    Time frame: 3 years

  55. Device success

    Time frame: 4 years

  56. Device success

    Time frame: 5 years

  57. Early safety as a composite of all cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, valve related dysfunction requiring repeat procedure

    Time frame: 1 month

  58. Clinical Efficacy as a composite of all cause mortality, all stroke, hospitalization for valve related symptoms or worsening congestive heart failure, NYHA class III or IV, prosthetic heart valve dysfunction

    Time frame: 1 month, 6 months, and annually at 1 to 5 years

  59. Time related valve safety as a composite of structural valve deterioration, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, VARC bleeding(unless clearly unrelated to valve therapy)

    Time frame: from index procedure to 5 years

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement for Patients With Bicuspid Aortic Valve Stenosis

Acronym: Bicuspid TAVR

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2015
Registry last updated
Dec 26, 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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