Clinical trial NCT03298178: ASAN Medical Center Aortic Valve Replacement Registry
Official title: ASAN Medical Center Aortic Valve Replacement Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: TAVR
TAVI
SAVR
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2017-10-02
Enrollment: 6000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All successful transcatheter aortic valve replacement or surgical aortic valve replacement

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

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria

* Infective endocarditis

Primary outcomes:
measure: All cause death
timeFrame: 1 year
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 1,6 and 12 months and 5 years
measure: Cardiovascular mortality
timeFrame: 1,6 and 12 months and 5 years
measure: Myocardial infarction
timeFrame: 1,6 and 12 months and 5 years
measure: Stroke
timeFrame: 1,6 and 12 months and 5 years
measure: Bleeding
timeFrame: 1,6 and 12 months and 5 years
measure: Operation site complication
timeFrame: 1,6 and 12 months and 5 years
measure: Vascular access site and access-related complication
timeFrame: 1,6 and 12 months and 5 years
measure: Acute kidney injury
timeFrame: at a later date between 30 days or discharge
measure: Event rate of permanent pacemaker insertion
timeFrame: 1,6 and 12 months and 5 years
measure: Other TAVR-related complication
timeFrame: 1,6 and 12 months and 5 years
measure: Prosthetic valve dysfunction
timeFrame: 1,6 and 12 months and 5 years
measure: Event rate of composite endpoint
timeFrame: 1,6 and 12 months and 5 years
measure: Structural valve deterioration
timeFrame: 1,6 and 12 months and 5 years
measure: Change of NYHA class
timeFrame: 30 days and 1 year
measure: Change of valve area
timeFrame: 30 days and 1 year
measure: Free from atrial fibrillation
timeFrame: 1,6 and 12 months and 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Hospital
Study officials:
affiliation: Asan Medical Center
name: Seung-jung Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.