The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry

NCT02394184 | Completed

• 1 other identifier: AMCCV2014-14_sub
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis; Cardiovascular Diseases; Heart Valve Diseases; Bicuspid

Keywords

transcatheter aortic valve replacement

Outcome Measures

Primary Outcomes (7)

• Death

  1 month

• Death

  6 months

• Death

  1 year

• Death

  2 years

• Death

  3 years

• Death

  4 years

• Death

  5 years

Secondary Outcomes (59)

• 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

Study Arms (1)

patients with bicuspid aortic valve stenosis

Procedure: transcatheter aortic valve replacement

Interventions

transcatheter aortic valve replacement PROCEDURE

patients with bicuspid aortic valve stenosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with bicuspid aortic valve stenosis

You may qualify if:

• 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.

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 27609682 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Cardiovascular Diseases; Heart Valve Diseases; Bicuspid Aortic Valve Disease

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• 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,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 20, 2015
• Study Start: May 1, 2015
• Primary Completion: September 24, 2019
• Study Completion: September 24, 2019
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)