The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry (Bicuspid TAVR)

Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement for Patients With Bicuspid Aortic Valve Stenosis

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Aortic Valve Stenosis; Heart Valve Diseases; Bicuspid
• Intervention / Treatment: Procedure: transcatheter aortic valve replacement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with bicuspid aortic valve stenosis

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with bicuspid aortic valve stenosis	Procedure: transcatheter aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death	3 years
Death	1 year
Death	5 years
Death	1 month
Death	6 months
Death	2 years
Death	4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Myocardial infarction	6 months
Myocardial infarction	3 years
Myocardial infarction	1 year
Stroke	5 years
Myocardial infarction	5 years
Stroke	4 years
Stroke	1 year
Death from cardiac cause	1 month
Death from cardiac cause	6 months
Death from cardiac cause	1 year
Death from cardiac cause	2 years
Death from cardiac cause	3 years
Death from cardiac cause	4 years
Death from cardiac cause	5 years
Stroke	1 month
Stroke	6 months
Stroke	2 years
Stroke	3 years
Myocardial infarction	1 month
Myocardial infarction	2 years
Myocardial infarction	4 years
Repeat hospitalization	1 month
Repeat hospitalization	6 months
Repeat hospitalization	1 year
Repeat hospitalization	2 years
Repeat hospitalization	3 years
Repeat hospitalization	4 years
Repeat hospitalization	5 years
Acute kidney injury	1 month
Acute kidney injury	6 months
Acute kidney injury	1 year
Acute kidney injury	2 years
Acute kidney injury	3 years
Acute kidney injury	4 years
Acute kidney injury	5 years
Vascular complication	1 month
Vascular complication	6 months
Vascular complication	1 year
Vascular complication	2 years
Vascular complication	3 years
Vascular complication	4 years
Vascular complication	5 years
Bleeding events	1 month
Bleeding events	6 months
Bleeding events	1 year
Bleeding events	2 years
Bleeding events	3 years
Bleeding events	4 years
Bleeding events	5 years
Device success	1 month
Device success	6 months
Device success	1 year
Device success	2 years
Device success	3 years
Device success	4 years
Device success	5 years
Early safety as a composite of all cause mortality, all stroke, life threatening bleeding, acute kidney injury, coronary artery obstruction requiring intervention, major vascular complication, valve related dysfunction requiring repeat procedure	1 month
Clinical Efficacy as a composite of all cause mortality, all stroke, hospitalization for valve related symptoms or worsening congestive heart failure, NYHA class III or IV, prosthetic heart valve dysfunction	1 month, 6 months, and annually at 1 to 5 years
Time related valve safety as a composite of structural valve deterioration, prosthetic valve endocarditis, prosthetic valve thrombosis, thromboembolic events, VARC bleeding(unless clearly unrelated to valve therapy)	from index procedure to 5 years

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Seung-jung Park, MD, PhD, Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine; Principal Investigator: Gerald Yong, MD, Perth Cardiovascular Institute, Royal Perth Hospital 197 Wellington Street, Perth WA 6000, Australia; Principal Investigator: Edgar Tay, MD, Department of Cardiology, National University Hospital Singapore, 5 Lower Kent Ridge Road, Singapore 119074, Singapore; Principal Investigator: Fabian Nietlispach, MD, PhD, Department of Cardiology, University Heart Center, Raemistrasse 100, CH-8091 Zurich, Switzerland; Principal Investigator: Corrado Tamburino, MD, Division of Cardiology, Ferrarotto Hospital, University of Catania; ETNA Foundation Via Citelli 6, 95124, Catania, Italy; Principal Investigator: Thierry Lefèvre, MD, Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, France; Principal Investigator: Marie-Claude Morice, MD, Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, France; Principal Investigator: Jeroen J. Bax, MD, PhD, Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands; Principal Investigator: John G. Webb, MD, St. Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada; Principal Investigator: Susheel Kodali, MD, Herbert and Sandi Feinberg Interventional Cardiology, Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital, 177 Fort Washington Avenue,

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): September 24, 2019
• Study Completion (Actual): September 24, 2019

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 19, 2015
• First Posted (Estimate): March 20, 2015

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 22, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: transcatheter aortic valve replacement
• Additional Relevant MeSH Terms: Heart Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Aortic Valve Stenosis; Constriction, Pathologic; Heart Valve Diseases; Bicuspid Aortic Valve Disease
• Other Study ID Numbers: AMCCV2014-14_sub

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This is not a publicly funded trial.