The Asian Pacific TAVR Multicenter Registry

Aortic Valve Stenosis Clinical Trial

— AP TAVR  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02195102
• Other study ID #: AMCCV 2013-12
• Status: Not yet recruiting
• Phase: N/A
• First received: July 11, 2014
• Last updated: November 17, 2014
• Start date: December 2014
• Est. completion date: December 2021

Study information

• Verified date: November 2014
• Source: Queen Elizabeth Hospital, Hong Kong
• Contact: Elly Jeong-youn Bae, Research Nurse
• Email: cvcrc10[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Transcatheter aortic valve Replacement

Locations

Country	Name	City	State
China	Queen Elizabeth Hospital	HongKong
China	Nanjing 1st Hospital	Nanjing
Japan	Shonan Kamakura General Hospital	Kamakura
Korea, Republic of	Asan Medical Center	Seoul
Malaysia	Institut Jantung Negara	Kuala Lumpur
Philippines	St. Luke's Medical Center	Bonifacio
Singapore	National Heart Centre of Singapore	Singapore
Singapore	National University Heart Centre	Singapore
Taiwan	National Taiwan University	Taipei
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
Michael Kang-Yin Lee, MD	Asan Medical Center, Cardiovascular Clinical Research

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from any cause		1 month	Yes
Primary	Death from any cause		6 months	Yes
Primary	Death from any cause		1 year	Yes
Primary	Death from any cause		2 years	Yes
Primary	Death from any cause		3 years	Yes
Primary	Death from any cause		4 years	Yes
Primary	Death from any cause		5 years	Yes
Secondary	Death from cardiac cause		1 month	Yes
Secondary	Death from cardiac cause		6 months	Yes
Secondary	Death from cardiac cause		1 year	Yes
Secondary	Death from cardiac cause		2 years	Yes
Secondary	Death from cardiac cause		3 years	Yes
Secondary	Death from cardiac cause		4 years	Yes
Secondary	Death from cardiac cause		5 years	Yes
Secondary	Stroke		1 month	Yes
Secondary	Stroke		6 months	Yes
Secondary	Stroke		1 year	Yes
Secondary	Stroke		2 years	Yes
Secondary	Stroke		3 years	Yes
Secondary	Stroke		4 years	Yes
Secondary	Stroke		5 years	Yes
Secondary	Myocardial infarction		1 month	Yes
Secondary	Myocardial infarction		6 months	Yes
Secondary	Myocardial infarction		1 year	Yes
Secondary	Myocardial infarction		2 years	Yes
Secondary	Myocardial infarction		3 years	Yes
Secondary	Myocardial infarction		4 years	Yes
Secondary	Myocardial infarction		5 years	Yes
Secondary	Repeat hospitalization		1 month	Yes
Secondary	Repeat hospitalization		6 months	Yes
Secondary	Repeat hospitalization		1 year	Yes
Secondary	Repeat hospitalization		2 years	Yes
Secondary	Repeat hospitalization		3 years	Yes
Secondary	Repeat hospitalization		4 years	Yes
Secondary	Repeat hospitalization		5 years	Yes
Secondary	Acute kidney injury		1 month	Yes
Secondary	Acute kidney injury		6 months	Yes
Secondary	Acute kidney injury		1 year	Yes
Secondary	Acute kidney injury		2 years	Yes
Secondary	Acute kidney injury		3 years	Yes
Secondary	Acute kidney injury		4 years	Yes
Secondary	Acute kidney injury		5 years	Yes
Secondary	Vascular complication		1 month	Yes
Secondary	Vascular complication		6 months	Yes
Secondary	Vascular complication		1 year	Yes
Secondary	Vascular complication		2 years	Yes
Secondary	Vascular complication		3 years	Yes
Secondary	Vascular complication		4 years	Yes
Secondary	Vascular complication		5 years	Yes
Secondary	Bleeding events		1 month	Yes
Secondary	Bleeding events		6 months	Yes
Secondary	Bleeding events		1 year	Yes
Secondary	Bleeding events		2 years	Yes
Secondary	Bleeding events		3 years	Yes
Secondary	Bleeding events		4 years	Yes
Secondary	Bleeding events		5 years	Yes
Secondary	Device success	Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)	1 month	No
Secondary	Device success	Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)	6 months	No
Secondary	Device success	Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)	1 year	No
Secondary	Device success	Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)	2 years	No
Secondary	Device success	Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)	3 years	No
Secondary	Device success	Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)	4 years	No
Secondary	Device success	Absence of procedural mortality and correct positioning of a single prosthetic valve into the proper anatomical location with intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20 mmHg or peak velocity < 3 m/s, and no moderate or severe paravalvular regurgitation)	5 years	No