Mitroflow DL Post Approval Study- North America

Study Overview
=================
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.

Official Title
-----------------
Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study

Conditions
-----------------
Aortic Stenosis, Aortic Regurgitation, Aortic Valve Insufficiency, Heart Valve Diseases, Cardiovascular Abnormalities, Cardiovascular Diseases, Congenital Abnormalities, Heart Diseases, Pathological Conditions, Anatomical

Intervention / Treatment
-----------------
* Device: Mitroflow DL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients is indicated for Mitroflow DL implantation according to the Instructions for Use (IFU). Patient or patient's legal representative is willing to sign the informed consent. Patient's preoperative evaluation indicated the need for native or prosthetic aortic valve replacement 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 Patient is able to return for all follow-up evaluations for the duration of the study (geographically stable). Exclusion Criteria: Patient is contra-indicated for Mitroflow DL implantation according to the Instructions for Use. The patient has a pre-existing valve prosthesis in the mitral, pulmonary, or tricsupid position. Patient requires a double or triple valve replacement (repair is not considered an exclusion). Patient has active endocarditis or myocarditis. Patient is pregnant or lactating. Patient is participating in a concomitant research study of an investigational product.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitroflow DL<br>Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL) | Device: Mitroflow DL<br>* Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)<br>* Other names: Mitroflow Pericardial Aortic Heart Valve with PRT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of structural Valve Deterioration in Implanted Patients | To establish rates of structural valve deterioration through 8 years follow-up | 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 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 | 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 | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic valve replacement, aortic stenosis, aortic steno-insufficiency