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Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

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ClinicalTrials.gov Identifier: NCT03836521
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Raj Makkar, Cedars-Sinai Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Bicuspid Aortic Valve Device: Transcatheter aortic valve replacement

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The International Multicenter Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry
Actual Study Start Date : August 15, 2016
Estimated Primary Completion Date : August 15, 2028
Estimated Study Completion Date : August 15, 2028

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 129 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All consecutive patients presenting with severe and symptomatic bicuspid aortic valve stenosis or mixed disease
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age <18 years
  2. Asymptomatic patients
  3. Pure aortic regurgitation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836521


Contacts
Contact: Sung-Han Yoon, M.D. 3104237426 Sunghan.Yoon@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Sung-Han Yoon, M.D.    310-423-7426    Sunghan.Yoon@cshs.org   
Sponsors and Collaborators
Cedars-Sinai Medical Center

Responsible Party: Raj Makkar, Profssor of Medicine, University of California, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03836521     History of Changes
Other Study ID Numbers: Pro00047203
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction