NCT02195102

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

50
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
8 countries

10 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

July 11, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

6.7 years

First QC Date

July 11, 2014

Last Update Submit

November 17, 2014

Conditions

Aortic Valve Stenosis

Keywords

transcatheter aortic valve Replacement

Outcome Measures

Primary Outcomes (7)

  • 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

  • Death from any cause

    4 years

  • Death from any cause

    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

Study Arms (1)

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

Interventions

Transcatheter aortic valve ReplacementDEVICE
transcatheter aortic valve Replacement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

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 (10)

Queen Elizabeth Hospital

Hong Kong, China

Location

Nanjing 1st Hospital

Nanjing, China

Location

Shonan Kamakura General Hospital

Kamakura, Japan

Location

Institut Jantung Negara

Kuala Lumpur, Malaysia

Location

St. Luke's Medical Center

Bonifacio, Philippines

Location

National Heart Centre of Singapore

Singapore, Singapore

Location

National University Heart Centre

Singapore, Singapore

Location

Asan Medical Center

Seoul, South Korea

Location

National Taiwan University

Taipei, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

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

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elly Jeong-youn Bae, Research Nurse

CONTACT

cvcrc10@amc.seoul.kr

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 21, 2014

Study Start

December 1, 2014

Primary Completion

August 1, 2021

Study Completion

December 1, 2021

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

PH(1)MY(1)CN(2)KR(1)JP(1)TW(1)SG(2)TH(1)