Summary

at UCLA
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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.

Keywords

Aortic Stenosis Aortic Regurgitation Aortic Valve Insufficiency Heart Valve Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Heart Diseases Pathological Conditions, Anatomical aortic valve replacement aortic steno-insufficiency Aortic Valve Stenosis Mitroflow DL

Eligibility

You can join if…

  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).

You CAN'T join if...

  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.

Locations

  • UCLA Medical Center
    Los Angeles California 90095 United States
  • Sharp Memorial Hospital
    San Diego California 92123 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
LivaNova
ID
NCT02351726
Study Type
Interventional
Last Updated