Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
NCT ID: NCT02276547
Last Updated: 2025-05-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
27 participants
INTERVENTIONAL
2014-12-31
2025-08-31
Brief Summary
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Detailed Description
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A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum of 15 subjects will be implanted in the United States.
Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a transcatheter mitral valve replacement (TMVR) procedure.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Transcatheter mitral valve replacement with the TIARA valve and transapical delivery system
Mitral valve replacement
Transcatheter mitral valve replacement
Interventions
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Mitral valve replacement
Transcatheter mitral valve replacement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* High surgical risk for open mitral valve surgery
* Subject meets the anatomical eligibility criteria for available size(s)
* NYHA Class III or IV heart failure
Exclusion Criteria
* Prohibitive risk, deemed too frail or listed for cardiac transplant.
* Unsuitable cardiac structure
18 Years
ALL
No
Sponsors
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Shockwave Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anson Cheung, MD
Role: STUDY_CHAIR
University of British Columbia
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
University of Washington Medical Center
Seattle, Washington, United States
ZNA Middelheim
Antwerp, , Belgium
University of Alberta
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Countries
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References
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De Backer O, Piazza N, Banai S, Lutter G, Maisano F, Herrmann HC, Franzen OW, Sondergaard L. Percutaneous transcatheter mitral valve replacement: an overview of devices in preclinical and early clinical evaluation. Circ Cardiovasc Interv. 2014 Jun;7(3):400-9. doi: 10.1161/CIRCINTERVENTIONS.114.001607. No abstract available.
Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD, Anderson JL, Halperin JL, Albert NM, Bozkurt B, Brindis RG, Creager MA, Curtis LH, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Ohman EM, Pressler SJ, Sellke FW, Shen WK, Stevenson WG, Yancy CW; American College of Cardiology; American College of Cardiology/American Heart Association; American Heart Association. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Thorac Cardiovasc Surg. 2014 Jul;148(1):e1-e132. doi: 10.1016/j.jtcvs.2014.05.014. Epub 2014 May 9. No abstract available.
Kappetein AP, Head SJ, Genereux P, Piazza N, van Mieghem NM, Blackstone EH, Brott TG, Cohen DJ, Cutlip DE, van Es GA, Hahn RT, Kirtane AJ, Krucoff MW, Kodali S, Mack MJ, Mehran R, Rodes-Cabau J, Vranckx P, Webb JG, Windecker S, Serruys PW, Leon MB; Valve Academic Research Consortium-2. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. J Thorac Cardiovasc Surg. 2013 Jan;145(1):6-23. doi: 10.1016/j.jtcvs.2012.09.002. Epub 2012 Oct 16.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Company website with product information
Other Identifiers
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047-CPT-001
Identifier Type: -
Identifier Source: org_study_id
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