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Trial record 8 of 452 for:    aortic valve replacement

The Asian Pacific TAVR Multicenter Registry (AP TAVR)

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ClinicalTrials.gov Identifier: NCT02195102
Recruitment Status : Not yet recruiting
First Posted : July 21, 2014
Last Update Posted : November 18, 2014
Sponsor:
Collaborators:
Asan Medical Center
Cardiovascular Clinical Research
Information provided by (Responsible Party):
Michael Kang-Yin Lee, MD, Queen Elizabeth Hospital, Hong Kong

Brief Summary:
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population

Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: Transcatheter aortic valve Replacement

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Official Title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Population The Asian Pacific TAVI Multicenter Registry A MULTICENTER, OBSERVATIONAL STUDY
Study Start Date : December 2014
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
transcatheter aortic valve Replacement
Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
Device: Transcatheter aortic valve Replacement



Primary Outcome Measures :
  1. Death from any cause [ Time Frame: 1 month ]
  2. Death from any cause [ Time Frame: 6 months ]
  3. Death from any cause [ Time Frame: 1 year ]
  4. Death from any cause [ Time Frame: 2 years ]
  5. Death from any cause [ Time Frame: 3 years ]
  6. Death from any cause [ Time Frame: 4 years ]
  7. Death from any cause [ 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 ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  51. Device success [ Time Frame: 6 months ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  52. Device success [ Time Frame: 1 year ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  53. Device success [ Time Frame: 2 years ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  54. Device success [ Time Frame: 3 years ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  55. Device success [ Time Frame: 4 years ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)

  56. Device success [ Time Frame: 5 years ]
    Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who had undergone transcatheter aortic valve replacement on the basis of inclusion criteria were prospectively&retrospectively included in the registry
Criteria

Inclusion Criteria:

  • Patients with symptomatic severe aortic 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.

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): NCT02195102


Contacts
Contact: Elly Jeong-youn Bae, Research Nurse cvcrc10@amc.seoul.kr

Locations
China
Queen Elizabeth Hospital Not yet recruiting
HongKong, China
Contact: Michael Kang-Yin Lee, MD       kylee1991@hotmail.com   
Principal Investigator: Michael Kang-Yin Lee, MD         
Nanjing 1st Hospital Not yet recruiting
Nanjing, China
Contact: Jun-Jie Zhang, MD       jameszll@163.com   
Principal Investigator: Jun-Jie Zhang, MD         
Japan
Shonan Kamakura General Hospital Not yet recruiting
Kamakura, Japan
Contact: Shigeru Saito, MD       saito@shonankamakura.or.jp   
Principal Investigator: Shigeru Saito, MD         
Korea, Republic of
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Jeong-youn Bae, Research nurse       cvcrc10@amc.seoul.kr   
Principal Investigator: Seung-jung Park, MD, PhD         
Malaysia
Institut Jantung Negara Not yet recruiting
Kuala Lumpur, Malaysia
Contact: Rosli Mohd Ali, MD       rosli@ijn.com.my   
Principal Investigator: Rosli Mohd Ali, MD         
Philippines
St. Luke's Medical Center Not yet recruiting
Bonifacio, Philippines
Contact: Enrique Fabio Posas, MD       febposas@gmail.com   
Principal Investigator: Enrique Fabio Posas, MD         
Singapore
National Heart Centre of Singapore Not yet recruiting
Singapore, Singapore
Contact: Paul Chiam, MD       paul.chiam.t.l@nhcs.com.sg   
Principal Investigator: Paul Chiam, MD         
National University Heart Centre Not yet recruiting
Singapore, Singapore
Contact: Edgar L.W. Tay, MD       Edgar_Tay@nuhs.edu.sg   
Principal Investigator: Edgar L.W. Tay, MD         
Taiwan
National Taiwan University Not yet recruiting
Taipei, Taiwan
Contact: Paul Kao, MD       hsienli_kao@yahoo.com   
Principal Investigator: Paul Kao, MD         
Thailand
King Chulalongkorn Memorial Hospital Not yet recruiting
Bangkok, Thailand
Contact: Wacin Buddhari, MD       wacin_buddhari@yahoo.com   
Principal Investigator: Wacin Buddhari, MD         
Sponsors and Collaborators
Michael Kang-Yin Lee, MD
Asan Medical Center
Cardiovascular Clinical Research
Investigators
Principal Investigator: Seung-jung Park, MD, PhD Asan Medical Center, Republic of Korea
Principal Investigator: Edgar L.W. Tay, MD National University Heart Center (National University Health System), Singapore
Principal Investigator: Machael Kang-Yin Lee, MD Queen Elizabeth Hospital, HongKong

Responsible Party: Michael Kang-Yin Lee, MD, MD, Queen Elizabeth Hospital, Hong Kong
ClinicalTrials.gov Identifier: NCT02195102     History of Changes
Other Study ID Numbers: AMCCV 2013-12
First Posted: July 21, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Michael Kang-Yin Lee, MD, Queen Elizabeth Hospital, Hong Kong:
transcatheter aortic valve Replacement

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