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.
This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who are at high risk for open chest surgery. 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Transcatheter mitral valve replacement
Cedars Sinai Medical Center
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
Henry Ford Health System
Detroit, Michigan, United States
Freedom From All-cause Mortality and Major Adverse Events
Defined as disabling stroke, myocardial infarction, renal failure requiring dialysis, life-threatening bleeding, and cardiac surgical or transcatheter reintervention
Time frame: From the time of implant procedure to 30 days or hospital discharge (whichever is later)
Number and Percentage of Subjects With All-cause Mortality, Disabling Stroke, Myocardial Infarction, Renal Failure Requiring Dialysis, Life-threatening Bleeding and Cardiac Surgical or Transcatheter Reintervention
Time frame: 30 days, 90 days, 180 days and annually to five years
Individual 30 Day Rates of Device and Procedure Related Major Adverse Events
1. All mortality 2. All stroke 3. Residual MR \> mild (1+) 4. Life threatening bleeding 5. Acute kidney injury Grade 3 6. New pacemaker/LBBB 7. Coronary occlusion/myocardial infarction 8. Urgent/emergent surgery or reintervention
Time frame: 30 days
Number and Percentage of Subjects With Progression of Heart Failure
Readmission for Heart Failure Need for Heart Failure device implantation Cardiac transplantation Listing for transplantation
Time frame: One year
Device Success; Delivery and Deployment of the Device in the Correct Position and Retrieval of Delivery Catheter
Mitral regurgitation \< moderate (2+) Effective valve orifice area ≥ 1.5 cm2 as assessed by post-procedural echocardiogram Mitral Valve gradient \< 5 mmHg No migration No fracture No endocarditis Stroke free No additional valve/access related interventional or surgical procedures
Time frame: Post procedure, discharge, 30 days, 90 days, 180 days and annually for five years
Performance
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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
Clinical performance as measured by NYHA Functional Class, 6MWT, and the KCCQ Hemodynamic performance as assessed by echocardiography: mean MV gradient, mitral regurgitation, effective orifice area of the MV, LV systolic and diastolic dimensions as well as volume Stroke free survival Original intended device in place No additional valve/access-related interventional or surgical procedures
Time frame: 30 days, 90 days, 180 days and annually for five years
Days Alive and Out of Hospital
Number of days alive and not hospitalized
Time frame: At one year