Clinical trial NCT02394184: The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry
Official title: Evaluation of Clinical Outcomes of Transcatheter Aortic Valve Replacement for Patients With Bicuspid Aortic Valve Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Cardiovascular Diseases
Heart Valve Diseases
Bicuspid
Keywords: transcatheter aortic valve replacement
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2015-03-20
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with bicuspid aortic valve stenosis

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Death
timeFrame: 1 month
measure: Death
timeFrame: 6 months
measure: Death
timeFrame: 1 year
measure: Death
timeFrame: 2 years
measure: Death
timeFrame: 3 years
measure: Death
timeFrame: 4 years
measure: Death
timeFrame: 5 years
Secondary outcomes:
measure: Death from cardiac cause
timeFrame: 1 month
measure: Death from cardiac cause
timeFrame: 6 months
measure: Death from cardiac cause
timeFrame: 1 year
measure: Death from cardiac cause
timeFrame: 2 years
measure: Death from cardiac cause
timeFrame: 3 years
measure: Death from cardiac cause
timeFrame: 4 years
measure: Death from cardiac cause
timeFrame: 5 years
measure: Stroke
timeFrame: 1 month
measure: Stroke
timeFrame: 6 months
measure: Stroke
timeFrame: 1 year
measure: Stroke
timeFrame: 2 years
measure: Stroke
timeFrame: 3 years
measure: Stroke
timeFrame: 4 years
measure: Stroke
timeFrame: 5 years
measure: Myocardial infarction
timeFrame: 1 month
measure: Myocardial infarction
timeFrame: 6 months
measure: Myocardial infarction
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 2 years
measure: Myocardial infarction
timeFrame: 3 years
measure: Myocardial infarction
timeFrame: 4 years
measure: Myocardial infarction
timeFrame: 5 years
measure: Repeat hospitalization
timeFrame: 1 month
measure: Repeat hospitalization
timeFrame: 6 months
measure: Repeat hospitalization
timeFrame: 1 year
measure: Repeat hospitalization
timeFrame: 2 years
measure: Repeat hospitalization
timeFrame: 3 years
measure: Repeat hospitalization
timeFrame: 4 years
measure: Repeat hospitalization
timeFrame: 5 years
measure: Acute kidney injury
timeFrame: 1 month
measure: Acute kidney injury
timeFrame: 6 months
measure: Acute kidney injury
timeFrame: 1 year
measure: Acute kidney injury
timeFrame: 2 years
measure: Acute kidney injury
timeFrame: 3 years
measure: Acute kidney injury
timeFrame: 4 years
measure: Acute kidney injury
timeFrame: 5 years
measure: Vascular complication
timeFrame: 1 month
measure: Vascular complication
timeFrame: 6 months
measure: Vascular complication
timeFrame: 1 year
measure: Vascular complication
timeFrame: 2 years
measure: Vascular complication
timeFrame: 3 years
measure: Vascular complication
timeFrame: 4 years
measure: Vascular complication
timeFrame: 5 years
measure: Bleeding events
timeFrame: 1 month
measure: Bleeding events
timeFrame: 6 months
measure: Bleeding events
timeFrame: 1 year
measure: Bleeding events
timeFrame: 2 years
measure: Bleeding events
timeFrame: 3 years
measure: Bleeding events
timeFrame: 4 years
measure: Bleeding events
timeFrame: 5 years
measure: Device success
timeFrame: 1 month
measure: Device success
timeFrame: 6 months
measure: Device success
timeFrame: 1 year
measure: Device success
timeFrame: 2 years
measure: Device success
timeFrame: 3 years
measure: Device success
timeFrame: 4 years
measure: Device success
timeFrame: 5 years
measure: 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
timeFrame: 1 month
measure: 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
timeFrame: 1 month, 6 months, and annually at 1 to 5 years
measure: 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)
timeFrame: from index procedure to 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Division of Cardiology, Department of Medicine, Heart Institute, Asan Medical Center, University of Ulsan College of Medicine
name: Seung-jung Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Perth Cardiovascular Institute, Royal Perth Hospital 197 Wellington Street, Perth WA 6000, Australia
name: Gerald Yong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, National University Hospital Singapore, 5 Lower Kent Ridge Road, Singapore 119074, Singapore
name: Edgar Tay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, University Heart Center, Raemistrasse 100, CH-8091 Zurich, Switzerland
name: Fabian Nietlispach, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Ferrarotto Hospital, University of Catania; ETNA Foundation Via Citelli 6, 95124, Catania, Italy
name: Corrado Tamburino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, France
name: Thierry Lefèvre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Hospitalier Jacques Cartier, 6 avenue du Noyer Lambert, FR-91300 Massy, France
name: Marie-Claude Morice, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands
name: Jeroen J. Bax, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Paul's Hospital, University of British Columbia, 1081 Burrard Street, Vancouver, BC V6Z 1Y6, Canada
name: John G. Webb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herbert and Sandi Feinberg Interventional Cardiology, Heart Valve Center at Columbia University Medical Center/New York-Presbyterian Hospital, 177 Fort Washington Avenue,
name: Susheel Kodali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.