An interventional study of Mitroflow DL in Aortic Stenosis, Aortic Regurgitation and Aortic Valve Insufficiency, sponsored by LivaNova. Terminated at 13 sites in United States. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by LivaNova · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 186 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
Device: Mitroflow DL
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
Also known as: Mitroflow Pericardial Aortic Heart Valve with PRT
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
This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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