The Asian Pacific TAVR Multicenter Registry (AP TAVR)

November 17, 2014 updated by: Michael Kang-Yin Lee, MD

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Death from any cause
Time Frame: 4 years
4 years
Death from any cause
Time Frame: 5 years
5 years
Death from any cause
Time Frame: 1 month
1 month
Death from any cause
Time Frame: 6 months
6 months
Death from any cause
Time Frame: 1 year
1 year
Death from any cause
Time Frame: 2 years
2 years
Death from any cause
Time Frame: 3 years
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Myocardial infarction
Time Frame: 6 months
6 months
Myocardial infarction
Time Frame: 3 years
3 years
Myocardial infarction
Time Frame: 1 year
1 year
Stroke
Time Frame: 5 years
5 years
Myocardial infarction
Time Frame: 5 years
5 years
Stroke
Time Frame: 4 years
4 years
Stroke
Time Frame: 1 year
1 year
Death from cardiac cause
Time Frame: 1 month
1 month
Death from cardiac cause
Time Frame: 6 months
6 months
Death from cardiac cause
Time Frame: 1 year
1 year
Death from cardiac cause
Time Frame: 2 years
2 years
Death from cardiac cause
Time Frame: 3 years
3 years
Death from cardiac cause
Time Frame: 4 years
4 years
Death from cardiac cause
Time Frame: 5 years
5 years
Stroke
Time Frame: 1 month
1 month
Stroke
Time Frame: 6 months
6 months
Stroke
Time Frame: 2 years
2 years
Stroke
Time Frame: 3 years
3 years
Myocardial infarction
Time Frame: 1 month
1 month
Myocardial infarction
Time Frame: 2 years
2 years
Myocardial infarction
Time Frame: 4 years
4 years
Repeat hospitalization
Time Frame: 1 month
1 month
Repeat hospitalization
Time Frame: 6 months
6 months
Repeat hospitalization
Time Frame: 1 year
1 year
Repeat hospitalization
Time Frame: 2 years
2 years
Repeat hospitalization
Time Frame: 3 years
3 years
Repeat hospitalization
Time Frame: 4 years
4 years
Repeat hospitalization
Time Frame: 5 years
5 years
Acute kidney injury
Time Frame: 1 month
1 month
Acute kidney injury
Time Frame: 6 months
6 months
Acute kidney injury
Time Frame: 1 year
1 year
Acute kidney injury
Time Frame: 2 years
2 years
Acute kidney injury
Time Frame: 3 years
3 years
Acute kidney injury
Time Frame: 4 years
4 years
Acute kidney injury
Time Frame: 5 years
5 years
Vascular complication
Time Frame: 1 month
1 month
Vascular complication
Time Frame: 6 months
6 months
Vascular complication
Time Frame: 1 year
1 year
Vascular complication
Time Frame: 2 years
2 years
Vascular complication
Time Frame: 3 years
3 years
Vascular complication
Time Frame: 4 years
4 years
Vascular complication
Time Frame: 5 years
5 years
Bleeding events
Time Frame: 1 month
1 month
Bleeding events
Time Frame: 6 months
6 months
Bleeding events
Time Frame: 1 year
1 year
Bleeding events
Time Frame: 2 years
2 years
Bleeding events
Time Frame: 3 years
3 years
Bleeding events
Time Frame: 4 years
4 years
Bleeding events
Time Frame: 5 years
5 years
Device success
Time Frame: 1 month
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
Time Frame: 6 months
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
Time Frame: 1 year
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
Time Frame: 2 years
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
Time Frame: 3 years
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
Time Frame: 4 years
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
Time Frame: 5 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Michael Kang-Yin Lee, MD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Asan Medical Center
Cardiovascular Clinical Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMCCV 2013-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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