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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT02195102
Date of registration:	11/07/2014
Prospective Registration:	Yes
Primary sponsor:	Michael Kang-Yin Lee, MD
Public title:	The Asian Pacific TAVR Multicenter Registry AP TAVR
Scientific title:	Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Population The Asian Pacific TAVI Multicenter Registry A MULTICENTER, OBSERVATIONAL STUDY
Date of first enrolment:	December 2014
Target sample size:	2000
Recruitment status:	Not yet recruiting
URL:	http://clinicaltrials.gov/show/NCT02195102
Study type:	Observational
Study design:	Observational Model: Cohort
Phase:	N/A

Countries of recruitment
China	Japan	Korea, Republic of	Malaysia	Philippines	Singapore	Taiwan	Thailand

Contacts

Name:	Elly Jeong-youn Bae, Research Nurse
Address:
Telephone:
Email:	cvcrc10@amc.seoul.kr
Affiliation:

Name:	Edgar L.W. Tay, MD
Address:
Telephone:
Email:
Affiliation:	National University Heart Center (National University Health System), Singapore

Name:	Seung-jung Park, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Asan Medical Center, Republic of Korea

Name:	Machael Kang-Yin Lee, MD
Address:
Telephone:
Email:
Affiliation:	Queen Elizabeth Hospital, HongKong

Key inclusion & exclusion 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.

Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Aortic Valve Stenosis

Intervention(s)

Device: Transcatheter aortic valve Replacement

Primary Outcome(s)

Death from any cause [Time Frame: 5 years]

Death from any cause [Time Frame: 6 months]

Death from any cause [Time Frame: 2 years]

Death from any cause [Time Frame: 1 month]

Death from any cause [Time Frame: 1 year]

Death from any cause [Time Frame: 3 years]

Death from any cause [Time Frame: 4 years]

Secondary Outcome(s)

Acute kidney injury [Time Frame: 5 years]

Acute kidney injury [Time Frame: 6 months]

Bleeding events [Time Frame: 3 years]

Death from cardiac cause [Time Frame: 4 years]

Bleeding events [Time Frame: 5 years]

Death from cardiac cause [Time Frame: 5 years]

Device success [Time Frame: 1 month]

Device success [Time Frame: 1 year]

Myocardial infarction [Time Frame: 6 months]

Repeat hospitalization [Time Frame: 6 months]

Stroke [Time Frame: 1 month]

Stroke [Time Frame: 4 years]

Acute kidney injury [Time Frame: 3 years]

Bleeding events [Time Frame: 4 years]

Death from cardiac cause [Time Frame: 2 years]

Device success [Time Frame: 3 years]

Myocardial infarction [Time Frame: 1 year]

Repeat hospitalization [Time Frame: 3 years]

Death from cardiac cause [Time Frame: 6 months]

Device success [Time Frame: 5 years]

Device success [Time Frame: 6 months]

Myocardial infarction [Time Frame: 1 month]

Acute kidney injury [Time Frame: 4 years]

Bleeding events [Time Frame: 2 years]

Stroke [Time Frame: 3 years]

Acute kidney injury [Time Frame: 1 year]

Bleeding events [Time Frame: 1 year]

Death from cardiac cause [Time Frame: 1 month]

Device success [Time Frame: 4 years]

Vascular complication [Time Frame: 1 year]

Acute kidney injury [Time Frame: 2 years]

Death from cardiac cause [Time Frame: 3 years]

Repeat hospitalization [Time Frame: 4 years]

Stroke [Time Frame: 2 years]

Stroke [Time Frame: 5 years]

Myocardial infarction [Time Frame: 3 years]

Vascular complication [Time Frame: 2 years]

Device success [Time Frame: 2 years]

Repeat hospitalization [Time Frame: 1 year]

Repeat hospitalization [Time Frame: 2 years]

Stroke [Time Frame: 1 year]

Vascular complication [Time Frame: 6 months]

Myocardial infarction [Time Frame: 4 years]

Vascular complication [Time Frame: 1 month]

Vascular complication [Time Frame: 3 years]

Vascular complication [Time Frame: 4 years]

Vascular complication [Time Frame: 5 years]

Acute kidney injury [Time Frame: 1 month]

Bleeding events [Time Frame: 1 month]

Bleeding events [Time Frame: 6 months]

Death from cardiac cause [Time Frame: 1 year]

Myocardial infarction [Time Frame: 2 years]

Myocardial infarction [Time Frame: 5 years]

Repeat hospitalization [Time Frame: 1 month]

Repeat hospitalization [Time Frame: 5 years]

Stroke [Time Frame: 6 months]

Secondary ID(s)

AMCCV 2013-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Asan Medical Center

Cardiovascular Clinical Research

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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