Mitroflow DL Post Approval Study- North America

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02351726
Study type	Interventional
Source	LivaNova
Contact
Status	Terminated
Phase	N/A
Start date	March 2015
Completion date	December 31, 2019

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