Active — Not RecruitingNot Applicable

Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System

United States27 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Freedom From All-cause Mortality and Major Adverse Events

Timeframe: From the time of implant procedure to 30 days or hospital discharge (whichever is later)

Trial details

NCT IDNCT02276547

SponsorShockwave Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-01-06

Results submitted2021-04-30

View on ClinicalTrials.gov More Mitral Valve Regurgitation trials