ASAN Medical Center Aortic Valve Replacement Registry (ASAN-AVR)

June 29, 2023 updated by: Ho-Jin Kim
This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All TAVR and SAVR cases will be enrolled retrospectively and prospectively.

This registry includes sub group analysis named STRATEGY AS(Role of Sarcopenia and frailTy in pRedicting outcomes After TranscathEter or surGical aortic valve replacement in elderlY patients with Aortic Stenosis: A prospective cohort study). For this sub group analysis, all enrolled subjects will have following tests : EQ-5D, KCCQ-12(Kansas City Cardiomyopathy Questionnaire), ADL(Activities of daily living), IADL(Instrumental. Activities of Daily Living), Nagi & Rosow-Breslau self-reported items, Previous fall events since 6 months (initial) or last visit(F/U), IPAQ(The International Physical Activity Questionnaires), Social frailty screening, CES-D(Center for Epidemiologic Studies Depression Scale), MNA-SF(Mini Nutritional Assessment - Short Form),SPPB score (Short Physical Performance Battery, usual gait speed, balance, chairstand), Multi-task gait test (counting7, animal, motor, motor&counting7), Grip strength, Bioimpedance analysis, Muscle tone at thigh and calf, UEF (Upper extremities function).

Study Type

Observational

Enrollment (Estimated)

6000

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 Locations

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All successful transcatheter aortic valve replacement or surgical aortic valve replacement

Description

Inclusion Criteria:

  • All successful transcatheter aortic valve replacement or surgical aortic valve replacement
  • Written consent

Exclusion Criteria

  • Infective endocarditis

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
all aortic stenosis
Procedure: TAVR
All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea
Other Names:
  • transcatheter aortic valve replacement
Procedure: SAVR
All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause death
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 1,6 and 12 months and 5 years
1,6 and 12 months and 5 years
Cardiovascular mortality
Time Frame: 1,6 and 12 months and 5 years
Death due to proximate cardiac cause Death caused by noncoronary vascular condition All procedure-related/surgery-related death All valve-related death Sudden or unwitnessed death Death of unknown cause
1,6 and 12 months and 5 years
Myocardial infarction
Time Frame: 1,6 and 12 months and 5 years
1,6 and 12 months and 5 years
Stroke
Time Frame: 1,6 and 12 months and 5 years
all stroke and TIA
1,6 and 12 months and 5 years
Bleeding
Time Frame: 1,6 and 12 months and 5 years
1,6 and 12 months and 5 years
Operation site complication
Time Frame: 1,6 and 12 months and 5 years
1,6 and 12 months and 5 years
Vascular access site and access-related complication
Time Frame: 1,6 and 12 months and 5 years
1,6 and 12 months and 5 years
Acute kidney injury
Time Frame: at a later date between 30 days or discharge
at a later date between 30 days or discharge
Event rate of permanent pacemaker insertion
Time Frame: 1,6 and 12 months and 5 years
1,6 and 12 months and 5 years
Other TAVR-related complication
Time Frame: 1,6 and 12 months and 5 years
Conversion to open surgery Coronary obstruction Mitral valve apparatus damage or dysfunction Cardiac tamponade Endocarditis Valve thrombosis Valve malpositioning TAV-in-TAV deployment(TAV : Transcatheter Aortic Valve)
1,6 and 12 months and 5 years
Prosthetic valve dysfunction
Time Frame: 1,6 and 12 months and 5 years
Prosthetic aortic valve stenosis Prosthesis-patient mismatch Prosthetic aortic valve regurgitation
1,6 and 12 months and 5 years
Event rate of composite endpoint
Time Frame: 1,6 and 12 months and 5 years
Device success Early safety within 30 days Clinical efficacy after 30 days defined as death, stroke, valve dysfunction or heart failure requiring hospitalization, severe dyspnea or valve dysfunction NYHA class III or IV
1,6 and 12 months and 5 years
Structural valve deterioration
Time Frame: 1,6 and 12 months and 5 years
1,6 and 12 months and 5 years
Change of NYHA class
Time Frame: 30 days and 1 year
the New York Heart Association (NYHA) Functional Classification
30 days and 1 year
Change of valve area
Time Frame: 30 days and 1 year
30 days and 1 year
Free from atrial fibrillation
Time Frame: 1,6 and 12 months and 5 years
1,6 and 12 months and 5 years

Collaborators and Investigators

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

Sponsor

Ho-Jin Kim

Collaborators

CardioVascular Research Foundation, Korea

Investigators

  • Principal Investigator: Seung-jung Park, MD, Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

December 1, 2017

Primary Completion (Estimated)

December 15, 2030

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

September 26, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMCCV 2017-09

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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