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TERMINATEDNA

Mitroflow DL Post Approval Study- North America

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

NCT02351726•LivaNova

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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.

Locations (13)

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

Key Dates

Start Date

March 1, 2015

Primary Completion Date

December 31, 2019

Completion Date

December 31, 2019

Last Updated

February 20, 2020

Enrollment

186

ACTUAL participants

Conditions

Aortic StenosisAortic RegurgitationAortic Valve InsufficiencyHeart Valve DiseasesCardiovascular AbnormalitiesCardiovascular DiseasesCongenital AbnormalitiesHeart DiseasesPathological Conditions, Anatomical

Interventions

Mitroflow DL

DEVICE

The ARTEMIS Data Collection Study

NCT07075861

Aortic Regurgitation Disease

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RECRUITINGNA

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

NCT06689839

Aortic Stenosis Treated With TAVIAortic Diseases

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RECRUITINGNA

Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Mitroflow DL Post Approval Study- North America

Inclusion Criteria

Exclusion Criteria

The ARTEMIS Data Collection Study

Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR

Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)

Pivotal Study of the Vienna Transcatheter Self Expandable Aortic Valve SE System

Comparison of Evolut FX Versus Sapien 3 Ultra Resilia.

Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement