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The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry (Bicuspid TAVR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02394184
Recruitment Status : Recruiting
First Posted : March 20, 2015
Last Update Posted : June 20, 2017
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Aortic Valve Stenosis Cardiovascular Diseases Heart Valve Diseases Bicuspid Procedure: transcatheter aortic valve replacement

Study Design

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement for Patients With Bicuspid Aortic Valve Stenosis
Study Start Date : May 2015
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
patients with bicuspid aortic valve stenosis Procedure: transcatheter aortic valve replacement

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with bicuspid aortic valve stenosis

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.
Contacts and Locations

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): NCT02394184

Contact: Sung-Han Yoon, MD yunsonhan@gmail.com
Contact: Jung-Hee Ham, Project leader cvcrc5@amc.seoul.kr

Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-jung park, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Principal Investigator: Seung-jung Park, MD, PhD Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine
Principal Investigator: Gerald Yong, MD Perth Cardiovascular Institute, Royal Perth Hospital 197 Wellington Street, Perth WA 6000, Australia
Principal Investigator: Edgar Tay, MD Department of Cardiology, National University Hospital Singapore, 5 Lower Kent Ridge Road, Singapore 119074, Singapore
Principal Investigator: Fabian Nietlispach, MD, PhD Department of Cardiology, University Heart Center, Raemistrasse 100, CH-8091 Zurich, Switzerland
Principal Investigator: Corrado Tamburino, MD Division of Cardiology, Ferrarotto Hospital, University of Catania; ETNA Foundation Via Citelli 6, 95124, Catania, Italy
Principal Investigator: Thierry Lefèvre, MD Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, France
Principal Investigator: Marie-Claude Morice, MD Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, France
Principal Investigator: Jeroen J. Bax, MD, PhD Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands
Principal Investigator: John G. Webb, MD St. Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada
Principal Investigator: Susheel Kodali, MD Herbert and Sandi Feinberg Interventional Cardiology, Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital, 177 Fort Washington Avenue,
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seung-Jung Park, MD, PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02394184     History of Changes
Other Study ID Numbers: AMCCV2014-14_sub
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is not a publicly funded trial.

Keywords provided by Seung-Jung Park, Asan Medical Center:
transcatheter aortic valve replacement

Additional relevant MeSH terms:
Cardiovascular Diseases
Constriction, Pathologic
Aortic Valve Stenosis
Heart Valve Diseases
Pathological Conditions, Anatomical
Heart Diseases
Ventricular Outflow Obstruction