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Completed
NCT02276547
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
Conditions: Mitral Valve Regurgitation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 27
Sponsor: Shockwave Medical, Inc.
Location: Cedars Sinai Medical Center Los Angeles California
Summary
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
Eligibility Criteria
Inclusion Criteria:
* Severe symptomatic mitral regurgitation (Stage D)
* 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:
* DMR deemed by the heart team to be operable.
* Prohibitive risk, deemed too frail or listed for cardiac transplant.
* Unsuitable cardiac structure
Source: ClinicalTrials.gov (NCT02276547). StuddyBuddy aggregates publicly available trial information.
