Aortic Valve StenosisAsian TAVRNCT02308150
The Asian Transcatheter Aortic Valve Replacement Registry
An observational study of Aortic Valve Stenosis and Aortic Diseases, run by Seung-Jung Park at 12 sites in 5 countries.
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, Aortic Diseases
- What is being tested?
- transcatheter aortic valve replacement
- Type of treatment
- Medical device
- How many people
- 1,505 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Dec 2014to 24 Sep 2019
- 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 will undergo TAVR in Asian Pacific countries
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
12 sites in 5 countries.
12 sites in 5 countries
Japan5 sites
Shonan Kamakura General Hospital
Kamakura
Kokura Memorial Hospital
Kitakyushu
Keio University
Minato
Teikyo University School of medicine
Tokyo
Saiseikai Yokohama-city Eastern Hospital
Yokohama
South Korea4 sites
Sejong Hospital
Bucheon-si
Chungnam National University Hospital
Daejeon
Asan Medical Center
Seoul, Songpa-gu, 138-736
Seoul National University Hospital
Seoul
About this study
Official title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Pacific Population
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in the Asian Pacific population
Read the detailed description
This registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.
- Conditions
- Aortic Valve Stenosis, Aortic Diseases
- Being tested
- transcatheter aortic valve replacement
- Keywords
- transcatheter aortic valve replacement, asian pacific, asian
- Medical subject headings
- Aortic Valve Stenosis, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter aortic valve replacementDevice
Also called TAVR
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: 1 month
Death
Measured: 6 months
Death
Measured: 1 year
Death
Measured: 2 years
Death
Measured: 3 years
Death
Measured: 4 years
Death
Measured: 5 years
Secondary outcomes (56)
Death from cardiac cause
Measured: 1 month
Death from cardiac cause
Measured: 6 months
Death from cardiac cause
Measured: 1 year
Death from cardiac cause
Measured: 2 years
Death from cardiac cause
Measured: 3 years
Death from cardiac cause
Measured: 4 years
Death from cardiac cause
Measured: 5 years
Stroke
Measured: 1 month
Stroke
Measured: 6 months
Stroke
Measured: 1 year
Stroke
Measured: 2 years
Stroke
Measured: 3 years
Stroke
Measured: 4 years
Stroke
Measured: 5 years
Myocardial infarction
Measured: 1 month
Myocardial infarction
Measured: 6 months
Myocardial infarction
Measured: 1 year
Myocardial infarction
Measured: 2 years
Myocardial infarction
Measured: 3 years
Myocardial infarction
Measured: 4 years
Myocardial infarction
Measured: 5 years
Repeat hospitalization
Measured: 1 month
Repeat hospitalization
Measured: 6 months
Repeat hospitalization
Measured: 1 year
Repeat hospitalization
Measured: 2 years
Repeat hospitalization
Measured: 3 years
Repeat hospitalization
Measured: 4 years
Repeat hospitalization
Measured: 5 years
Acute kidney injury
Measured: 1 month
Acute kidney injury
Measured: 6 months
Acute kidney injury
Measured: 1 year
Acute kidney injury
Measured: 2 years
Acute kidney injury
Measured: 3 years
Acute kidney injury
Measured: 4 years
Acute kidney injury
Measured: 5 years
Vascular complication
Measured: 1 month
Vascular complication
Measured: 6 months
Vascular complication
Measured: 1 year
Vascular complication
Measured: 2 years
Vascular complication
Measured: 3 years
Vascular complication
Measured: 4 years
Vascular complication
Measured: 5 years
Bleeding events
Measured: 1 month
Bleeding events
Measured: 6 months
Bleeding events
Measured: 1 year
Bleeding events
Measured: 2 years
Bleeding events
Measured: 3 years
Bleeding events
Measured: 4 years
Bleeding events
Measured: 5 years
Device success
Measured: 1 month
Device success
Measured: 6 months
Device success
Measured: 1 year
Device success
Measured: 2 years
Device success
Measured: 3 years
Device success
Measured: 4 years
Device success
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startDec 2014
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Time perspective
- Prospective
- Enrolment
- 1,505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
- Investigators
- Seung-jung Park, MD, Principal investigator, Asan Medical CenterPaul Hsien Li Kao, MD, Principal investigator, National Taiwan UniversityShigeru Saito, MD, Principal investigator, Shonan Kamakura General Hospital, JapanGerald Yong, MD, Principal investigator, Royal Perth Hospital, AustraliaKentaro Hayashida, MD, Principal investigator, Keio University, JAPAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308150
- Sponsor's protocol ID
- AMCCV2014-14
- Acronym
- Asian TAVR
- Status last verified
- Sep 2019
- First submitted
- 2 Dec 2014
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is not a publicly funded trial.
Publications
Yoon SH, Ahn JM, Hayashida K, Watanabe Y, Shirai S, Kao HL, Yin WH, Lee MK, Tay E, Araki M, Yamanaka F, Arai T, Lin MS, Park JB, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Muramatsu T, Hanyu M, Kozuma K, Kim HS, Saito S, Park SJ; Asian TAVR Investigators. Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population. JACC Cardiovasc Interv. 2016 May 9;9(9):926-33. doi: 10.1016/j.jcin.2016.01.047.
PubMed 27151607
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Pacific Population
- ClinicalTrials.gov ID
- NCT02308150
- Acronym / sponsor ID
- Asian TAVR / AMCCV2014-14
- Conditions
- Aortic Valve Stenosis, Aortic Diseases
- Keywords
- transcatheter aortic valve replacement, asian pacific, asian
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,505 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Dec 2014
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in the Asian Pacific population
Detailed description
This registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who will undergo TAVR in Asian Pacific countries
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcatheter aortic valve replacementAlso: TAVR | Device | – |
Primary outcome
Death
Time frame: 1 month
Death
Time frame: 6 months
Death
Time frame: 1 year
Death
Time frame: 2 years
Death
Time frame: 3 years
Death
Time frame: 4 years
Death
Time frame: 5 years
56 secondary outcomes
Death from cardiac cause
Time frame: 1 month
Death from cardiac cause
Time frame: 6 months
Death from cardiac cause
Time frame: 1 year
Death from cardiac cause
Time frame: 2 years
Death from cardiac cause
Time frame: 3 years
Death from cardiac cause
Time frame: 4 years
Death from cardiac cause
Time frame: 5 years
Stroke
Time frame: 1 month
Stroke
Time frame: 6 months
Stroke
Time frame: 1 year
Stroke
Time frame: 2 years
Stroke
Time frame: 3 years
Stroke
Time frame: 4 years
Stroke
Time frame: 5 years
Myocardial infarction
Time frame: 1 month
Myocardial infarction
Time frame: 6 months
Myocardial infarction
Time frame: 1 year
Myocardial infarction
Time frame: 2 years
Myocardial infarction
Time frame: 3 years
Myocardial infarction
Time frame: 4 years
Myocardial infarction
Time frame: 5 years
Repeat hospitalization
Time frame: 1 month
Repeat hospitalization
Time frame: 6 months
Repeat hospitalization
Time frame: 1 year
Repeat hospitalization
Time frame: 2 years
Repeat hospitalization
Time frame: 3 years
Repeat hospitalization
Time frame: 4 years
Repeat hospitalization
Time frame: 5 years
Acute kidney injury
Time frame: 1 month
Acute kidney injury
Time frame: 6 months
Acute kidney injury
Time frame: 1 year
Acute kidney injury
Time frame: 2 years
Acute kidney injury
Time frame: 3 years
Acute kidney injury
Time frame: 4 years
Acute kidney injury
Time frame: 5 years
Vascular complication
Time frame: 1 month
Vascular complication
Time frame: 6 months
Vascular complication
Time frame: 1 year
Vascular complication
Time frame: 2 years
Vascular complication
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Derived from this study: PubMed 27151607Yoon SH, Ahn JM, Hayashida K, Watanabe Y, Shirai S, Kao HL, Yin WH, Lee MK, Tay E, Araki M, Yamanaka F, Arai T, Lin MS, Park JB, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Muramatsu T, Hanyu M, Kozuma K, Kim HS, Saito S, Park SJ; Asian TAVR Investigators. Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population. JACC Cardiovasc Interv. 2016 May 9;9(9):926-33. doi: 10.1016/j.jcin.2016.01.047.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-jung Park, MD principal investigator
Asan Medical Center
Paul Hsien Li Kao, MD principal investigator
National Taiwan University
Shigeru Saito, MD principal investigator
Shonan Kamakura General Hospital, Japan
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Aortic Diseases, run by Seung-Jung Park at 12 sites in 5 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: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Japan, South Korea, China, Singapore, Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (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 NCT02308150, which also lists 1 linked publication.
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 25 Sep 2019.