Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry

• Sponsor: Cedars-Sinai Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03836521
• Collaborator: (none)
• Enrollment: 2,000
• Location: 1
• Anticipated Duration (Months): 144
• Patients Per Site Per Month: 13.9

Study Details

Study Description

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	Phase
Bicuspid Aortic Valve	Device: Transcatheter aortic valve replacement

Study Design

• Study Type: Observational
• Anticipated 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: Aug 15, 2016
• Anticipated Primary Completion Date: Aug 15, 2028
• Anticipated Study Completion Date: Aug 15, 2028

Outcome Measures

Primary Outcome Measures

1. Death [1 month]

   Death from any cause

2. Death [1 year]

   Death from any cause

3. Death [2 years]

   Death from any cause

4. Death [3 years]

   Death from any cause

5. Death [4 years]

   Death from any cause

6. Death [5 years]

   Death from any cause

Secondary Outcome Measures

1. Death from cardiac cause [1 month]

   Death from cardiac cause

2. Death from cardiac cause [1 year]

   Death from cardiac cause

3. Death from cardiac cause [2 years]

   Death from cardiac cause

4. Death from cardiac cause [3 years]

   Death from cardiac cause

5. Death from cardiac cause [4 years]

   Death from cardiac cause

6. Death from cardiac cause [5 years]

   Death from cardiac cause

7. Stroke [1 month]

   disabling and non-disabling stroke

8. Stroke [1 year]

   disabling and non-disabling stroke

9. Stroke [2 years]

   disabling and non-disabling stroke

10. Stroke [3 years]

    disabling and non-disabling stroke

11. Stroke [4 years]

    disabling and non-disabling stroke

12. Stroke [5 years]

    disabling and non-disabling stroke

13. Repeat hospitalization [1 month]

    Number of hospitalizations

14. Repeat hospitalization [1 year]

    Number of hospitalizations

15. Repeat hospitalization [2 years]

    Number of hospitalizations

16. Repeat hospitalization [3 years]

    Number of hospitalizations

17. Repeat hospitalization [4 years]

    Number of hospitalizations

18. Repeat hospitalization [5 years]

    Number of hospitalizations

19. Bleeding [1 month]

    Life-threatening or major bleeding rate

20. Bleeding [1 year]

    Life-threatening or major bleeding rate

21. Bleeding [2 years]

    Life-threatening or major bleeding rate

22. Bleeding [3 years]

    Life-threatening or major bleeding rate

23. Bleeding [4 years]

    Life-threatening or major bleeding rate

24. Bleeding [5 years]

    Life-threatening or major bleeding rate

25. Vascular complication [1 month]

    Major vascular complication

26. Vascular complication [1 year]

    Major vascular complication

27. Vascular complication [2 years]

    Major vascular complication

28. Vascular complication [3 years]

    Major vascular complication

29. Vascular complication [4 years]

    Major vascular complication

30. Vascular complication [5 years]

    Major vascular complication

31. Acute kidney injury (stage 2 or 3) [1 month]

32. Acute kidney injury (stage 2 or 3) [1 year]

33. Acute kidney injury (stage 2 or 3) [2 years]

34. Acute kidney injury (stage 2 or 3) [3 years]

35. Acute kidney injury (stage 2 or 3) [4 years]

36. Acute kidney injury (stage 2 or 3) [5 years]

37. Prosthetic regurgitation by Doppler echocardiography [at discharge]

38. Prosthetic regurgitation by Doppler echocardiography [1 month]

39. Prosthetic regurgitation by Doppler echocardiography [1 year]

40. Prosthetic regurgitation by Doppler echocardiography [2 years]

41. Prosthetic regurgitation by Doppler echocardiography [3 years]

42. Prosthetic regurgitation by Doppler echocardiography [4 years]

43. Prosthetic regurgitation by Doppler echocardiography [5 years]

44. Mean aortic valve gradient by Doppler echocardiography [1 month]

45. Mean aortic valve gradient by Doppler echocardiography [1 year]

46. Mean aortic valve gradient by Doppler echocardiography [2 years]

47. Mean aortic valve gradient by Doppler echocardiography [3 years]

48. Mean aortic valve gradient by Doppler echocardiography [4 years]

49. Mean aortic valve gradient by Doppler echocardiography [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 129 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048

Sponsors and Collaborators

• Cedars-Sinai Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raj Makkar, Profssor of Medicine, University of California, Cedars-Sinai Medical Center
• ClinicalTrials.gov Identifier: NCT03836521
• Other Study ID Numbers: Pro00047203
• First Posted: Feb 11, 2019
• Last Update Posted: Feb 11, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Aortic Valve Stenosis; Bicuspid Aortic Valve Disease; Heart Valve Diseases

Study Results

No Results Posted as of Feb 11, 2019