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Aortic Valve StenosisAP TAVRNCT02195102

The Asian Pacific TAVR Multicenter Registry

An observational study of Aortic Valve Stenosis, run by Michael Kang-Yin Lee, MD at 10 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve Replacement (TAVR) in the Asian Pacific population Read more about this study

Who is it for?
Any age
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
Transcatheter aortic valve Replacement
Type of treatment
Medical device
How many people
2,000 participants
Where
10 sitesin 8 countries
Study dates
Dec 2014to Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients who had undergone transcatheter aortic valve replacement on the basis of inclusion criteria were prospectively\&retrospectively included in the registry

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

10 sites in 8 countries.

Elly Jeong-youn Bae, Research Nurse contact

cvcrc10@amc.seoul.kr

10 sites in 8 countries

China2 sites

  • Queen Elizabeth Hospital

    Hong Kong

    Michael Kang-Yin Lee, MD, kylee1991@hotmail.com

    Michael Kang-Yin Lee, MD

  • Nanjing 1st Hospital

    Nanjing

    Jun-Jie Zhang, MD, jameszll@163.com

    Jun-Jie Zhang, MD

Other trials in China

Singapore2 sites

  • National Heart Centre of Singapore

    Singapore

    Paul Chiam, MD, paul.chiam.t.l@nhcs.com.sg

    Paul Chiam, MD

  • National University Heart Centre

    Singapore

    Edgar L.W. Tay, MD, Edgar_Tay@nuhs.edu.sg

    Edgar L.W. Tay, MD

Other trials in Singapore

Japan1 site

  • Shonan Kamakura General Hospital

    Kamakura

    Shigeru Saito, MD, saito@shonankamakura.or.jp

    Shigeru Saito, MD

Other trials in Japan

Malaysia1 site

  • Institut Jantung Negara

    Kuala Lumpur

    Rosli Mohd Ali, MD, rosli@ijn.com.my

    Rosli Mohd Ali, MD

Other trials in Malaysia

Philippines1 site

  • St. Luke's Medical Center

    Bonifacio

    Enrique Fabio Posas, MD, febposas@gmail.com

    Enrique Fabio Posas, MD

Other trials in Philippines

South Korea1 site

  • Asan Medical Center

    Seoul

    Jeong-youn Bae, Research nurse, cvcrc10@amc.seoul.kr

    Seung-jung Park, MD, PhD

Other trials in South Korea

Taiwan1 site

  • National Taiwan University

    Taipei

    Paul Kao, MD, hsienli_kao@yahoo.com

    Paul Kao, MD

Other trials in Taiwan

Thailand1 site

  • King Chulalongkorn Memorial Hospital

    Bangkok

    Wacin Buddhari, MD, wacin_buddhari@yahoo.com

    Wacin Buddhari, MD

Other trials in Thailand

About this study

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

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

Being tested
Transcatheter aortic valve Replacement
Keywords
transcatheter aortic valve Replacement
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter aortic valve ReplacementDevice

Study groups in NCT02195102
Study groupRoleWhat they receive
transcatheter aortic valve ReplacementPatients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.
Receives: Device: Transcatheter aortic valve Replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Death from any cause

    Measured: 1 month

  2. Death from any cause

    Measured: 6 months

  3. Death from any cause

    Measured: 1 year

  4. Death from any cause

    Measured: 2 years

  5. Death from any cause

    Measured: 3 years

  6. Death from any cause

    Measured: 4 years

  7. Death from any cause

    Measured: 5 years

Secondary outcomes (56)

  1. Death from cardiac cause

    Measured: 1 month

  2. Death from cardiac cause

    Measured: 6 months

  3. Death from cardiac cause

    Measured: 1 year

  4. Death from cardiac cause

    Measured: 2 years

  5. Death from cardiac cause

    Measured: 3 years

  6. Death from cardiac cause

    Measured: 4 years

  7. Death from cardiac cause

    Measured: 5 years

  8. Stroke

    Measured: 1 month

  9. Stroke

    Measured: 6 months

  10. Stroke

    Measured: 1 year

  11. Stroke

    Measured: 2 years

  12. Stroke

    Measured: 3 years

  13. Stroke

    Measured: 4 years

  14. Stroke

    Measured: 5 years

  15. Myocardial infarction

    Measured: 1 month

  16. Myocardial infarction

    Measured: 6 months

  17. Myocardial infarction

    Measured: 1 year

  18. Myocardial infarction

    Measured: 2 years

  19. Myocardial infarction

    Measured: 3 years

  20. Myocardial infarction

    Measured: 4 years

  21. Myocardial infarction

    Measured: 5 years

  22. Repeat hospitalization

    Measured: 1 month

  23. Repeat hospitalization

    Measured: 6 months

  24. Repeat hospitalization

    Measured: 1 year

  25. Repeat hospitalization

    Measured: 2 years

  26. Repeat hospitalization

    Measured: 3 years

  27. Repeat hospitalization

    Measured: 4 years

  28. Repeat hospitalization

    Measured: 5 years

  29. Acute kidney injury

    Measured: 1 month

  30. Acute kidney injury

    Measured: 6 months

  31. Acute kidney injury

    Measured: 1 year

  32. Acute kidney injury

    Measured: 2 years

  33. Acute kidney injury

    Measured: 3 years

  34. Acute kidney injury

    Measured: 4 years

  35. Acute kidney injury

    Measured: 5 years

  36. Vascular complication

    Measured: 1 month

  37. Vascular complication

    Measured: 6 months

  38. Vascular complication

    Measured: 1 year

  39. Vascular complication

    Measured: 2 years

  40. Vascular complication

    Measured: 3 years

  41. Vascular complication

    Measured: 4 years

  42. Vascular complication

    Measured: 5 years

  43. Bleeding events

    Measured: 1 month

  44. Bleeding events

    Measured: 6 months

  45. Bleeding events

    Measured: 1 year

  46. Bleeding events

    Measured: 2 years

  47. Bleeding events

    Measured: 3 years

  48. Bleeding events

    Measured: 4 years

  49. Bleeding events

    Measured: 5 years

  50. Device success

    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)

    Measured: 1 month

  51. Device success

    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)

    Measured: 6 months

  52. Device success

    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)

    Measured: 1 year

  53. Device success

    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)

    Measured: 2 years

  54. Device success

    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)

    Measured: 3 years

  55. Device success

    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)

    Measured: 4 years

  56. Device success

    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)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionAug 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02195102
Sponsor's protocol ID
AMCCV 2013-12
Acronym
AP TAVR
Status last verified
Nov 2014
First submitted
11 Jul 2014
Last updated
18 Nov 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis, run by Michael Kang-Yin Lee, MD at 10 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China, Singapore, Japan, Malaysia, Philippines and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elly Jeong-youn Bae, Research Nurse (cvcrc10@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death from any cause (time frame: 1 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02195102.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014; AzTrials last refreshed its copy on 31 Oct 2026.

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