Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
The purpose of this clinical investigation is to evaluate the safety and efficacy of the Mitroflow DL valve when used to replace diseased or dysfunctional native or prosthetic aortic heart valves. The study will be conducted in a minimum of 15 centers in the United States. Patients will be evaluated at each of the following time intervals:preoperative, at implant, in the early postoperative period, at 1 year (between 11 and 13 months postoperatively), and annually for 8 years. The duration of the study is anticipated to be 8 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
186
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
UCLA Medical Center
Los Angeles, California, United States
Sharp Memorial Hospital
San Diego, California, United States
River City Clinical Research
Jacksonville, Florida, United States
Rate of structural Valve Deterioration in Implanted Patients
To establish rates of structural valve deterioration through 8 years follow-up
Time frame: 8 years
Early and Late Valve-Related Adverse Event Rates
To determine early and late valve-related adverse event rates, including valve thrombosis, thromboembolism, paravalvular leak (all and major), bleeding(all and major), and endocarditis, for Mitroflow DL are comparable to appropriate historical controls
Time frame: Early (30 days) and Late (> 30 days)
Early and Late Rates of hemolysis, non-structural valve dysfunction, valve-related embolism, re-operation, explant and death
To determine rates of hemolysis, non-structural dysfunction, valve-related embolism, reoperation, explant and death (all cause and valve-related)
Time frame: Early (30 days) and Late (> 30 days)
Hemodynamic Performance
To evaluate the hemodynamic performance of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature
Time frame: 8 years
Improvements in NYHA
To evaluate the overall improvements in patient condition by comparison of pre-operative and post-operative New York Heart Associate (NYHA) functional classification
Time frame: 8 years
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UF Health - Jacksonville
Jacksonville, Florida, United States
Watson Clinic Center for Research
Lakeland, Florida, United States
Suburban Hospital - John Hopkins Medicine
Bethesda, Maryland, United States
Bay Regional Medical Center
Bay City, Michigan, United States
St. John Hospital & Medical Center
Detroit, Michigan, United States
Catholic Medical Center
Manchester, New Hampshire, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States
...and 3 more locations