Cardiovascular Diseases Clinical Trial
Official title:
Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study
NCT number | NCT02351726 |
Other study ID # | TMT001 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | December 31, 2019 |
Verified date | February 2020 |
Source | LivaNova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.
Status | Terminated |
Enrollment | 186 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Bay Regional Medical Center | Bay City | Michigan |
United States | Suburban Hospital - John Hopkins Medicine | Bethesda | Maryland |
United States | University of Virginia Medical Center | Charlottesville | Virginia |
United States | St. John Hospital & Medical Center | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | River City Clinical Research | Jacksonville | Florida |
United States | UF Health - Jacksonville | Jacksonville | Florida |
United States | Watson Clinic Center for Research | Lakeland | Florida |
United States | UCLA Medical Center | Los Angeles | California |
United States | Catholic Medical Center | Manchester | New Hampshire |
United States | St. Joseph's Regional Medical Center | Paterson | New Jersey |
United States | Sharp Memorial Hospital | San Diego | California |
United States | Lankenau Medical Center | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
LivaNova |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of structural Valve Deterioration in Implanted Patients | To establish rates of structural valve deterioration through 8 years follow-up | 8 years | |
Secondary | 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) | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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 |
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