The Asian Pacific TAVR Multicenter Registry (AP TAVR)

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement in the Asian Population The Asian Pacific TAVI Multicenter Registry A MULTICENTER, OBSERVATIONAL STUDY

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

Study Overview

• Status: Unknown
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Transcatheter aortic valve Replacement

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
transcatheter aortic valve Replacement; Patients with symptomatic severe aortic stenosis who are not candidates for surgical aortic valve replacement because of coexisting illnesses.	Device: Transcatheter aortic valve Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death from any cause	4 years
Death from any cause	5 years
Death from any cause	1 month
Death from any cause	6 months
Death from any cause	1 year
Death from any cause	2 years
Death from any cause	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarction		6 months
Myocardial infarction		3 years
Myocardial infarction		1 year
Stroke		5 years
Myocardial infarction		5 years
Stroke		4 years
Stroke		1 year
Death from cardiac cause		1 month
Death from cardiac cause		6 months
Death from cardiac cause		1 year
Death from cardiac cause		2 years
Death from cardiac cause		3 years
Death from cardiac cause		4 years
Death from cardiac cause		5 years
Stroke		1 month
Stroke		6 months
Stroke		2 years
Stroke		3 years
Myocardial infarction		1 month
Myocardial infarction		2 years
Myocardial infarction		4 years
Repeat hospitalization		1 month
Repeat hospitalization		6 months
Repeat hospitalization		1 year
Repeat hospitalization		2 years
Repeat hospitalization		3 years
Repeat hospitalization		4 years
Repeat hospitalization		5 years
Acute kidney injury		1 month
Acute kidney injury		6 months
Acute kidney injury		1 year
Acute kidney injury		2 years
Acute kidney injury		3 years
Acute kidney injury		4 years
Acute kidney injury		5 years
Vascular complication		1 month
Vascular complication		6 months
Vascular complication		1 year
Vascular complication		2 years
Vascular complication		3 years
Vascular complication		4 years
Vascular complication		5 years
Bleeding events		1 month
Bleeding events		6 months
Bleeding events		1 year
Bleeding events		2 years
Bleeding events		3 years
Bleeding events		4 years
Bleeding events		5 years
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Michael Kang-Yin Lee, MD
• Collaborators: Asan Medical Center; Cardiovascular Clinical Research
• Investigators: Principal Investigator: Seung-jung Park, MD, PhD, Asan Medical Center, Republic of Korea; Principal Investigator: Edgar L.W. Tay, MD, National University Heart Center (National University Health System), Singapore; Principal Investigator: Machael Kang-Yin Lee, MD, Queen Elizabeth Hospital, HongKong

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 17, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: transcatheter aortic valve Replacement
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: AMCCV 2013-12