Aortic Regurgitation, Aortic Stenosis, Aortic Valve Insufficiency, Cardiovascular Abnormalities, Cardiovascular Diseases, Congenital Abnormalities, Heart Diseases, Heart Valve Diseases, Pathological Conditions, Anatomical
Conditions
Keywords
aortic valve replacement, aortic stenosis, aortic steno-insufficiency
Brief summary
Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
Detailed description
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.
Interventions
DEVICEMitroflow DL
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
Sponsors
LivaNova
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients is indicated for Mitroflow DL implantation according to the Instructions for Use (IFU). 2. Patient or patient's legal representative is willing to sign the informed consent. 3. Patient's preoperative evaluation indicated the need for native or prosthetic aortic valve replacement 4. Any patient amenable to aortic valve replacement with a biological prosthesis should be enrolled in the study, even in conjuction with valve repair, coronary artery bypass grafting and other procedures 5. Patient is able to return for all follow-up evaluations for the duration of the study (geographically stable).
Exclusion criteria
1. Patient is contra-indicated for Mitroflow DL implantation according to the Instructions for Use. 2. The patient has a pre-existing valve prosthesis in the mitral, pulmonary, or tricsupid position. 3. Patient requires a double or triple valve replacement (repair is not considered an exclusion). 4. Patient has active endocarditis or myocarditis. 5. Patient is pregnant or lactating. 6. Patient is participating in a concomitant research study of an investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of structural Valve Deterioration in Implanted Patients | 8 years | To establish rates of structural valve deterioration through 8 years follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early and Late Valve-Related Adverse Event Rates | Early (30 days) and Late (> 30 days) | 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 |
| Early and Late Rates of hemolysis, non-structural valve dysfunction, valve-related embolism, re-operation, explant and death | Early (30 days) and Late (> 30 days) | To determine rates of hemolysis, non-structural dysfunction, valve-related embolism, reoperation, explant and death (all cause and valve-related) |
| Hemodynamic Performance | 8 years | To evaluate the hemodynamic performance of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature |
| Improvements in NYHA | 8 years | To evaluate the overall improvements in patient condition by comparison of pre-operative and post-operative New York Heart Associate (NYHA) functional classification |
Countries
United States
Outcome results
None listed