ASAN Medical Center Aortic Valve Replacement Registry

NCT ID: NCT03298178

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2031-12-31

Brief Summary

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This study evaluates the effectiveness and safety of surgical aortic valve replacement and transcatheter aortic valve replacement in aortic Stenosis.

Detailed Description

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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).

Conditions

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Aortic Valve Stenosis

Keywords

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TAVR TAVI SAVR

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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all aortic stenosis

TAVR

Intervention Type PROCEDURE

All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea

SAVR

Intervention Type PROCEDURE

All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea

Interventions

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TAVR

All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea

Intervention Type PROCEDURE

SAVR

All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea

Intervention Type PROCEDURE

Other Intervention Names

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transcatheter aortic valve replacement

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Infective endocarditis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Ho-Jin Kim

OTHER

Sponsor Role lead

Responsible Party

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Ho-Jin Kim

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seung-jung Park, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ho-jin Kim, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Ho-jin Kim, MD

Role: primary

References

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Kim HJ, Kang DY, Park H, Ahn JM, Kim JB, Kim SO, Ok YJ, Lee SH, Pyo WK, Ko E, Lee SA, Kim DH, Park SJ, Park DW, Choo SJ. Comparison of Sutureless Bioprosthetic Valve With Surgical or TAVR for Severe Aortic Stenosis. JACC Asia. 2021 Oct 26;1(3):317-329. doi: 10.1016/j.jacasi.2021.08.007. eCollection 2021 Dec.

Reference Type DERIVED
PMID: 36341221 (View on PubMed)

Yang Y, Ahn JM, Kang DY, Ko E, Kim S, Kim TO, Kim JH, Lee J, Lee SA, Kim DH, Kim HJ, Kim JB, Choo SJ, Park SJ, Park DW. Implication of Different ECG Left Ventricular Hypertrophy in Patients Undergoing Transcatheter Aortic Valve Replacement. J Am Heart Assoc. 2022 Feb 15;11(4):e023647. doi: 10.1161/JAHA.121.023647. Epub 2022 Feb 3.

Reference Type DERIVED
PMID: 35112886 (View on PubMed)

Jeong YJ, Ahn JM, Kang DY, Park H, Ko E, Kim HJ, Kim JB, Choo SJ, Lee SA, Park SJ, Kim DH, Park DW. Incidence, Predictors, and Prognostic Impact of Immediate Improvement in Left Ventricular Systolic Function After Transcatheter Aortic Valve Implantation. Am J Cardiol. 2021 Aug 1;152:99-105. doi: 10.1016/j.amjcard.2021.04.037. Epub 2021 Jun 11.

Reference Type DERIVED
PMID: 34127247 (View on PubMed)

Other Identifiers

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AMCCV 2017-09

Identifier Type: -

Identifier Source: org_study_id