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Trial record 13 of 182 for:    Phospholipids

Mitroflow DL Post Approval Study- North America

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02351726
Recruitment Status : Active, not recruiting
First Posted : January 30, 2015
Last Update Posted : January 21, 2019
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Aortic Stenosis Aortic Regurgitation Aortic Valve Insufficiency Heart Valve Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Heart Diseases Pathological Conditions, Anatomical Device: Mitroflow DL Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 186 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study
Study Start Date : March 2015
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mitroflow DL
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
Device: Mitroflow DL
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
Other Name: Mitroflow Pericardial Aortic Heart Valve with PRT

Primary Outcome Measures :
  1. Rate of structural Valve Deterioration in Implanted Patients [ Time Frame: 8 years ]
    To establish rates of structural valve deterioration through 8 years follow-up

Secondary Outcome Measures :
  1. Early and Late Valve-Related Adverse Event Rates [ Time Frame: Early (30 days) and Late (> 30 days) ]
    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

  2. Early and Late Rates of hemolysis, non-structural valve dysfunction, valve-related embolism, re-operation, explant and death [ Time Frame: Early (30 days) and Late (> 30 days) ]
    To determine rates of hemolysis, non-structural dysfunction, valve-related embolism, reoperation, explant and death (all cause and valve-related)

  3. Hemodynamic Performance [ Time Frame: 8 years ]
    To evaluate the hemodynamic performance of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature

  4. Improvements in NYHA [ Time Frame: 8 years ]
    To evaluate the overall improvements in patient condition by comparison of pre-operative and post-operative New York Heart Associate (NYHA) functional classification

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02351726

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United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Florida
River City Clinical Research
Jacksonville, Florida, United States, 32207
UF Health - Jacksonville
Jacksonville, Florida, United States, 32209
Watson Clinic Center for Research
Lakeland, Florida, United States, 33805
United States, Maryland
Suburban Hospital - John Hopkins Medicine
Bethesda, Maryland, United States, 20814
United States, Michigan
Bay Regional Medical Center
Bay City, Michigan, United States, 48708
St. John Hospital & Medical Center
Detroit, Michigan, United States, 48236
United States, New Hampshire
Catholic Medical Center
Manchester, New Hampshire, United States, 03102
United States, New Jersey
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States, 07503
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
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Principal Investigator: John Kern, MD University of Virginia

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Responsible Party: LivaNova Identifier: NCT02351726     History of Changes
Other Study ID Numbers: TMT001
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Keywords provided by LivaNova:
aortic valve replacement
aortic stenosis
aortic steno-insufficiency
Additional relevant MeSH terms:
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Heart Diseases
Aortic Valve Stenosis
Heart Valve Diseases
Aortic Valve Insufficiency
Cardiovascular Abnormalities
Congenital Abnormalities
Pathological Conditions, Anatomical
Cardiovascular Diseases
Ventricular Outflow Obstruction