Clinical trial NCT02308150: The Asian Transcatheter Aortic Valve Replacement Registry
Official title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Pacific Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Aortic Diseases
Keywords: transcatheter aortic valve replacement
asian pacific
asian
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2014-12-04
Enrollment: 1505
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who will undergo TAVR in Asian Pacific countries

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Death
timeFrame: 1 month
measure: Death
timeFrame: 6 months
measure: Death
timeFrame: 1 year
measure: Death
timeFrame: 2 years
measure: Death
timeFrame: 3 years
measure: Death
timeFrame: 4 years
measure: Death
timeFrame: 5 years
Secondary outcomes:
measure: Death from cardiac cause
timeFrame: 1 month
measure: Death from cardiac cause
timeFrame: 6 months
measure: Death from cardiac cause
timeFrame: 1 year
measure: Death from cardiac cause
timeFrame: 2 years
measure: Death from cardiac cause
timeFrame: 3 years
measure: Death from cardiac cause
timeFrame: 4 years
measure: Death from cardiac cause
timeFrame: 5 years
measure: Stroke
timeFrame: 1 month
measure: Stroke
timeFrame: 6 months
measure: Stroke
timeFrame: 1 year
measure: Stroke
timeFrame: 2 years
measure: Stroke
timeFrame: 3 years
measure: Stroke
timeFrame: 4 years
measure: Stroke
timeFrame: 5 years
measure: Myocardial infarction
timeFrame: 1 month
measure: Myocardial infarction
timeFrame: 6 months
measure: Myocardial infarction
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 2 years
measure: Myocardial infarction
timeFrame: 3 years
measure: Myocardial infarction
timeFrame: 4 years
measure: Myocardial infarction
timeFrame: 5 years
measure: Repeat hospitalization
timeFrame: 1 month
measure: Repeat hospitalization
timeFrame: 6 months
measure: Repeat hospitalization
timeFrame: 1 year
measure: Repeat hospitalization
timeFrame: 2 years
measure: Repeat hospitalization
timeFrame: 3 years
measure: Repeat hospitalization
timeFrame: 4 years
measure: Repeat hospitalization
timeFrame: 5 years
measure: Acute kidney injury
timeFrame: 1 month
measure: Acute kidney injury
timeFrame: 6 months
measure: Acute kidney injury
timeFrame: 1 year
measure: Acute kidney injury
timeFrame: 2 years
measure: Acute kidney injury
timeFrame: 3 years
measure: Acute kidney injury
timeFrame: 4 years
measure: Acute kidney injury
timeFrame: 5 years
measure: Vascular complication
timeFrame: 1 month
measure: Vascular complication
timeFrame: 6 months
measure: Vascular complication
timeFrame: 1 year
measure: Vascular complication
timeFrame: 2 years
measure: Vascular complication
timeFrame: 3 years
measure: Vascular complication
timeFrame: 4 years
measure: Vascular complication
timeFrame: 5 years
measure: Bleeding events
timeFrame: 1 month
measure: Bleeding events
timeFrame: 6 months
measure: Bleeding events
timeFrame: 1 year
measure: Bleeding events
timeFrame: 2 years
measure: Bleeding events
timeFrame: 3 years
measure: Bleeding events
timeFrame: 4 years
measure: Bleeding events
timeFrame: 5 years
measure: Device success
timeFrame: 1 month
measure: Device success
timeFrame: 6 months
measure: Device success
timeFrame: 1 year
measure: Device success
timeFrame: 2 years
measure: Device success
timeFrame: 3 years
measure: Device success
timeFrame: 4 years
measure: Device success
timeFrame: 5 years
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
city: Minato
country: Japan
facility: Keio University
city: Tokyo
country: Japan
facility: Teikyo University School of medicine
city: Yokohama
country: Japan
facility: Saiseikai Yokohama-city Eastern Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
city: Bucheon
country: Korea, Republic of
facility: Sejong Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Singapore
country: Singapore
facility: National University Heart Centre
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: Asan Medical Center
name: Seung-jung Park, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University, Taiwan
name: Paul Hsien Li Kao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shonan Kamakura General Hospital, Japan
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Perth Hospital, Australia
name: Gerald Yong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Keio University, JAPAN
name: Kentaro Hayashida, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.