NCT02308150

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,505

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
5 countries

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

December 2, 2014

Last Update Submit

September 24, 2019

Conditions

Aortic Valve StenosisAortic Diseases

Keywords

transcatheter aortic valve replacementasian pacificasian

Outcome Measures

Primary Outcomes (7)

  • Death

    1 month

  • Death

    6 months

  • Death

    1 year

  • Death

    2 years

  • Death

    3 years

  • Death

    4 years

  • Death

    5 years

Secondary Outcomes (56)

  • 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

  • +51 more secondary outcomes

Interventions

transcatheter aortic valve replacementDEVICE
Also known as: TAVR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who will undergo TAVR in Asian Pacific countries

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Queen Elizabeth Hospital

Hong Kong, China

Location

Shonan Kamakura General Hospital

Kamakura, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Japan

Location

Keio University

Minato, Japan

Location

Teikyo University School of medicine

Tokyo, Japan

Location

Saiseikai Yokohama-city Eastern Hospital

Yokohama, Japan

Location

National University Heart Centre

Singapore, Singapore

Location

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Location

Sejong Hospital

Bucheon-si, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

National Taiwan University

Taipei, Taiwan

Location

Related Publications (1)

  • Yoon SH, Ahn JM, Hayashida K, Watanabe Y, Shirai S, Kao HL, Yin WH, Lee MK, Tay E, Araki M, Yamanaka F, Arai T, Lin MS, Park JB, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Muramatsu T, Hanyu M, Kozuma K, Kim HS, Saito S, Park SJ; Asian TAVR Investigators. Clinical Outcomes Following Transcatheter Aortic Valve Replacement in Asian Population. JACC Cardiovasc Interv. 2016 May 9;9(9):926-33. doi: 10.1016/j.jcin.2016.01.047.

    PMID: 27151607DERIVED

MeSH Terms

Conditions

Aortic Valve StenosisAortic Diseases

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionVascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Seung-jung Park, MD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

  • Paul Hsien Li Kao, MD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

  • Shigeru Saito, MD

    Shonan Kamakura General Hospital, Japan

    PRINCIPAL INVESTIGATOR

  • Gerald Yong, MD

    Royal Perth Hospital, Australia

    PRINCIPAL INVESTIGATOR

  • Kentaro Hayashida, MD

    Keio University, JAPAN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 4, 2014

Study Start

December 1, 2014

Primary Completion

September 24, 2019

Study Completion

September 24, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

This is not a publicly funded trial.

Locations

JP(5)CN(1)SG(1)KR(4)TW(1)