Mitroflow DL Post Approval Study- North America

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

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

Study Overview

• Status: Terminated
• Conditions: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Aortic Stenosis; Heart Valve Diseases; Aortic Regurgitation; Aortic Valve Insufficiency; Cardiovascular Abnormalities
• Intervention / Treatment: Device: Mitroflow DL

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.

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Mitroflow Pericardial Aortic Heart Valve with PRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of structural Valve Deterioration in Implanted Patients	To establish rates of structural valve deterioration through 8 years follow-up	8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early and Late Valve-Related Adverse Event Rates	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	Early (30 days) and Late (> 30 days)
Early and Late Rates of hemolysis, non-structural valve dysfunction, valve-related embolism, re-operation, explant and death	To determine rates of hemolysis, non-structural dysfunction, valve-related embolism, reoperation, explant and death (all cause and valve-related)	Early (30 days) and Late (> 30 days)
Hemodynamic Performance	To evaluate the hemodynamic performance of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature	8 years
Improvements in NYHA	To evaluate the overall improvements in patient condition by comparison of pre-operative and post-operative New York Heart Associate (NYHA) functional classification	8 years

Collaborators and Investigators

• Sponsor: LivaNova
• Investigators: Principal Investigator: John Kern, MD, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: January 27, 2015
• First Posted (Estimate): January 30, 2015

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 18, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: aortic valve replacement; aortic stenosis; aortic steno-insufficiency
• Additional Relevant MeSH Terms: Aortic Valve Disease; Ventricular Outflow Obstruction; Heart Diseases; Cardiovascular Diseases; Aortic Valve Stenosis; Congenital Abnormalities; Aortic Valve Insufficiency; Heart Valve Diseases; Cardiovascular Abnormalities; Pathological Conditions, Anatomical
• Other Study ID Numbers: TMT001