Clinical trial NCT03826264: Transpacific TAVR Registry
Official title: a Multinational Multicenter Prospective Transpacific TAVR Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Valve Diseases
Aortic Valve Insufficiency
Keywords: TAVR
TAVI
real-world
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2019-02-01
Enrollment: 10000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing TAVR

Brief summary: This registry evaluates the long-term outcome of Transcatheter aortic valve replacement (TAVR) in real-world clinical practice.

Detailed description: This study is connected with Asian TAVR registry(NCT02308150). Some subjects from Asian TAVR registry continue 10 years follow-up on this TP-TAVR registry.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing TAVR
* Informed consent

Primary outcomes:
measure: Event rate of all cause death
timeFrame: 1 year
Secondary outcomes:
measure: Event rate of cardiovascular death
timeFrame: 10 years
measure: Event rate of myocardial infarction
timeFrame: 10 years
measure: Event rate of cerebrovascular accident
timeFrame: 10 years
measure: Event rate of bleeding
timeFrame: 10 years
measure: Event rate of Vascular access site and access-related complication
timeFrame: 30 days
measure: Event rate of Acute kidney injury
timeFrame: 30 days
measure: Event rate of Permanent pacemaker insertion
timeFrame: 10 years
measure: Event rate of Other TAVR-related complication
timeFrame: 10 years
measure: Event rate of Prosthetic valve dysfunction
timeFrame: 10 years
measure: Event rate of Composite endpoint
timeFrame: 10 years
measure: Event rate of Structural valve deterioration
timeFrame: 10 years
measure: NYHA class
timeFrame: 30 days
measure: NYHA class
timeFrame: 1 year
measure: Valve area
timeFrame: 1 year
measure: Event rate of free from atrial fibrillation
timeFrame: 10 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Stanford University
name: Alan Ching Yuen Yeung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: James D. Flaherty, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kang DY, Ahn JM, Kim JB, Yeung A, Nishi T, Fearon W, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Park SY, Yun SC, Ko E, Park H, Lee SA, Kim DH, Kim HJ, Kim JB, Choo SJ, Park DW, Park SJ. Inter-racial differences in patients undergoing transcatheter aortic valve implantation. Heart. 2022 Sep 12;108(19):1562-1570. doi: 10.1136/heartjnl-2021-320364.
citation: Park H, Ahn JM, Kang DY, Kim JB, Yeung AC, Nishi T, Fearon WF, Cantey EP, Flaherty JD, Davidson CJ, Malaisrie SC, Kim S, Yun SC, Ko E, Lee SA, Kim DH, Kim HJ, Kim JB, Choo SJ, Park DW, Park SJ. Racial Differences in the Incidence and Impact of Prosthesis-Patient Mismatch After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2021 Dec 27;14(24):2670-2681. doi: 10.1016/j.jcin.2021.08.038. Epub 2021 Nov 24.