Mitroflow DL Post Approval Study- North America

Stopped early · Not applicable

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

In brief

Prospective, non-randomized, multicenter post-approval study to collect long term clinical and echographic data on Mitroflow DL patients.

Key facts

Study ID

NCT02351726

Run by

LivaNova

People needed

186

Starts

2015-03-01

Expected to finish

2019-12-31

Last updated by the study team

2020-02-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• Sharp Memorial Hospital — San Diego, California, 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
• 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
• Duke University Medical Center — Durham, North Carolina, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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