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The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry

NCT ID: NCT02394184

Last Updated: 2019-12-26

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

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2019-09-24

Brief Summary

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The purpose of this study is to evaluate the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis.

Detailed Description

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This registry is a subgroup of Asian TAVR registry(NCT02308150) and Asian TAVR registry changes to TP-TAVR registry(NCT03826264). Some subjects moved to TP-TAVR registry and continue to 10-year follow-up.

Conditions

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Aortic Valve Stenosis Cardiovascular Diseases Heart Valve Diseases Bicuspid

Keywords

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transcatheter aortic valve replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with bicuspid aortic valve stenosis

transcatheter aortic valve replacement

Intervention Type PROCEDURE

Interventions

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transcatheter aortic valve replacement

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with bicuspid aortic valve 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CardioVascular Research Foundation, Korea

OTHER

Sponsor Role collaborator

Seung-Jung Park

OTHER

Sponsor Role lead

Responsible Party

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Seung-Jung Park

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Seung-jung Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine

Gerald Yong, MD

Role: PRINCIPAL_INVESTIGATOR

Perth Cardiovascular Institute, Royal Perth Hospital 197 Wellington Street, Perth WA 6000, Australia

Edgar Tay, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, National University Hospital Singapore, 5 Lower Kent Ridge Road, Singapore 119074, Singapore

Fabian Nietlispach, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, University Heart Center, Raemistrasse 100, CH-8091 Zurich, Switzerland

Corrado Tamburino, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Cardiology, Ferrarotto Hospital, University of Catania; ETNA Foundation Via Citelli 6, 95124, Catania, Italy

Thierry Lefèvre, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, France

Marie-Claude Morice, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, France

Jeroen J. Bax, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands

John G. Webb, MD

Role: PRINCIPAL_INVESTIGATOR

St. Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada

Susheel Kodali, MD

Role: PRINCIPAL_INVESTIGATOR

Herbert and Sandi Feinberg Interventional Cardiology, Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital, 177 Fort Washington Avenue,

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Yoon SH, Lefevre T, Ahn JM, Perlman GY, Dvir D, Latib A, Barbanti M, Deuschl F, De Backer O, Blanke P, Modine T, Pache G, Neumann FJ, Ruile P, Arai T, Ohno Y, Kaneko H, Tay E, Schofer N, Holy EW, Luk NHV, Yong G, Lu Q, Kong WKF, Hon J, Kao HL, Lee M, Yin WH, Park DW, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Kim HS, Butter C, Khalique OK, Schaefer U, Nietlispach F, Kodali SK, Leon MB, Ye J, Chevalier B, Leipsic J, Delgado V, Bax JJ, Tamburino C, Colombo A, Sondergaard L, Webb JG, Park SJ. Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis. J Am Coll Cardiol. 2016 Sep 13;68(11):1195-1205. doi: 10.1016/j.jacc.2016.06.041.

Reference Type DERIVED
PMID: 27609682 (View on PubMed)

Other Identifiers

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AMCCV2014-14_sub

Identifier Type: -

Identifier Source: org_study_id