Clinical trial NCT02195102: The Asian Pacific TAVR Multicenter Registry
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Keywords: transcatheter aortic valve Replacement
Lead sponsor: Queen Elizabeth Hospital, Hong Kong
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Cardiovascular Clinical Research
First posted: 2014-07-21
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
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

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


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 from any cause
timeFrame: 1 month
measure: Death from any cause
timeFrame: 6 months
measure: Death from any cause
timeFrame: 1 year
measure: Death from any cause
timeFrame: 2 years
measure: Death from any cause
timeFrame: 3 years
measure: Death from any cause
timeFrame: 4 years
measure: Death from any cause
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: HongKong
country: China
facility: Queen Elizabeth Hospital
city: Nanjing
country: China
facility: Nanjing 1st Hospital
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara
city: Bonifacio
country: Philippines
facility: St. Luke's Medical Center
city: Singapore
country: Singapore
facility: National Heart Centre of Singapore
city: Singapore
country: Singapore
facility: National University Heart Centre
city: Taipei
country: Taiwan
facility: National Taiwan University
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
affiliation: Asan Medical Center, Republic of Korea
name: Seung-jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Heart Center (National University Health System), Singapore
name: Edgar L.W. Tay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Elizabeth Hospital, HongKong
name: Machael Kang-Yin Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: