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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02308150




Registration number
NCT02308150
Ethics application status
Date submitted
2/12/2014
Date registered
4/12/2014
Date last updated
25/09/2019

Titles & IDs
Public title
The Asian Transcatheter Aortic Valve Replacement Registry
Scientific title
Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Pacific Population
Secondary ID [1] 0 0
AMCCV2014-14
Universal Trial Number (UTN)
Trial acronym
Asian TAVR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Aortic Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - transcatheter aortic valve replacement

Treatment: Devices: transcatheter aortic valve replacement
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Death
Timepoint [1] 0 0
1 month
Primary outcome [2] 0 0
Death
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
Death
Timepoint [3] 0 0
1 year
Primary outcome [4] 0 0
Death
Timepoint [4] 0 0
2 years
Primary outcome [5] 0 0
Death
Timepoint [5] 0 0
3 years
Primary outcome [6] 0 0
Death
Timepoint [6] 0 0
4 years
Primary outcome [7] 0 0
Death
Timepoint [7] 0 0
5 years
Secondary outcome [1] 0 0
Death from cardiac cause
Timepoint [1] 0 0
1 month
Secondary outcome [2] 0 0
Death from cardiac cause
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Death from cardiac cause
Timepoint [3] 0 0
1 year
Secondary outcome [4] 0 0
Death from cardiac cause
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Death from cardiac cause
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Death from cardiac cause
Timepoint [6] 0 0
4 years
Secondary outcome [7] 0 0
Death from cardiac cause
Timepoint [7] 0 0
5 years
Secondary outcome [8] 0 0
Stroke
Timepoint [8] 0 0
1 month
Secondary outcome [9] 0 0
Stroke
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
Stroke
Timepoint [10] 0 0
1 year
Secondary outcome [11] 0 0
Stroke
Timepoint [11] 0 0
2 years
Secondary outcome [12] 0 0
Stroke
Timepoint [12] 0 0
3 years
Secondary outcome [13] 0 0
Stroke
Timepoint [13] 0 0
4 years
Secondary outcome [14] 0 0
Stroke
Timepoint [14] 0 0
5 years
Secondary outcome [15] 0 0
Myocardial infarction
Timepoint [15] 0 0
1 month
Secondary outcome [16] 0 0
Myocardial infarction
Timepoint [16] 0 0
6 months
Secondary outcome [17] 0 0
Myocardial infarction
Timepoint [17] 0 0
1 year
Secondary outcome [18] 0 0
Myocardial infarction
Timepoint [18] 0 0
2 years
Secondary outcome [19] 0 0
Myocardial infarction
Timepoint [19] 0 0
3 years
Secondary outcome [20] 0 0
Myocardial infarction
Timepoint [20] 0 0
4 years
Secondary outcome [21] 0 0
Myocardial infarction
Timepoint [21] 0 0
5 years
Secondary outcome [22] 0 0
Repeat hospitalization
Timepoint [22] 0 0
1 month
Secondary outcome [23] 0 0
Repeat hospitalization
Timepoint [23] 0 0
6 months
Secondary outcome [24] 0 0
Repeat hospitalization
Timepoint [24] 0 0
1 year
Secondary outcome [25] 0 0
Repeat hospitalization
Timepoint [25] 0 0
2 years
Secondary outcome [26] 0 0
Repeat hospitalization
Timepoint [26] 0 0
3 years
Secondary outcome [27] 0 0
Repeat hospitalization
Timepoint [27] 0 0
4 years
Secondary outcome [28] 0 0
Repeat hospitalization
Timepoint [28] 0 0
5 years
Secondary outcome [29] 0 0
Acute kidney injury
Timepoint [29] 0 0
1 month
Secondary outcome [30] 0 0
Acute kidney injury
Timepoint [30] 0 0
6 months
Secondary outcome [31] 0 0
Acute kidney injury
Timepoint [31] 0 0
1 year
Secondary outcome [32] 0 0
Acute kidney injury
Timepoint [32] 0 0
2 years
Secondary outcome [33] 0 0
Acute kidney injury
Timepoint [33] 0 0
3 years
Secondary outcome [34] 0 0
Acute kidney injury
Timepoint [34] 0 0
4 years
Secondary outcome [35] 0 0
Acute kidney injury
Timepoint [35] 0 0
5 years
Secondary outcome [36] 0 0
Vascular complication
Timepoint [36] 0 0
1 month
Secondary outcome [37] 0 0
Vascular complication
Timepoint [37] 0 0
6 months
Secondary outcome [38] 0 0
Vascular complication
Timepoint [38] 0 0
1 year
Secondary outcome [39] 0 0
Vascular complication
Timepoint [39] 0 0
2 years
Secondary outcome [40] 0 0
Vascular complication
Timepoint [40] 0 0
3 years
Secondary outcome [41] 0 0
Vascular complication
Timepoint [41] 0 0
4 years
Secondary outcome [42] 0 0
Vascular complication
Timepoint [42] 0 0
5 years
Secondary outcome [43] 0 0
Bleeding events
Timepoint [43] 0 0
1 month
Secondary outcome [44] 0 0
Bleeding events
Timepoint [44] 0 0
6 months
Secondary outcome [45] 0 0
Bleeding events
Timepoint [45] 0 0
1 year
Secondary outcome [46] 0 0
Bleeding events
Timepoint [46] 0 0
2 years
Secondary outcome [47] 0 0
Bleeding events
Timepoint [47] 0 0
3 years
Secondary outcome [48] 0 0
Bleeding events
Timepoint [48] 0 0
4 years
Secondary outcome [49] 0 0
Bleeding events
Timepoint [49] 0 0
5 years
Secondary outcome [50] 0 0
Device success
Timepoint [50] 0 0
1 month
Secondary outcome [51] 0 0
Device success
Timepoint [51] 0 0
6 months
Secondary outcome [52] 0 0
Device success
Timepoint [52] 0 0
1 year
Secondary outcome [53] 0 0
Device success
Timepoint [53] 0 0
2 years
Secondary outcome [54] 0 0
Device success
Timepoint [54] 0 0
3 years
Secondary outcome [55] 0 0
Device success
Timepoint [55] 0 0
4 years
Secondary outcome [56] 0 0
Device success
Timepoint [56] 0 0
5 years

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/09/2019
Sample size
Target
Accrual to date
Final
1505
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Japan
State/province [2] 0 0
Kamakura
Country [3] 0 0
Japan
State/province [3] 0 0
Kitakyushu
Country [4] 0 0
Japan
State/province [4] 0 0
Minato
Country [5] 0 0
Japan
State/province [5] 0 0
Tokyo
Country [6] 0 0
Japan
State/province [6] 0 0
Yokohama
Country [7] 0 0
Korea, Republic of
State/province [7] 0 0
Songpa-gu
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Bucheon
Country [9] 0 0
Korea, Republic of
State/province [9] 0 0
Daejeon
Country [10] 0 0
Korea, Republic of
State/province [10] 0 0
Seoul
Country [11] 0 0
Singapore
State/province [11] 0 0
Singapore
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Other
Name
Seung-Jung Park
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
CardioVascular Research Foundation, Korea
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve
replacement (TAVR) in the Asian Pacific population
Trial website
https://clinicaltrials.gov/ct2/show/NCT02308150
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Seung-jung Park, MD
Address 0 0
Asan Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02308150