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Mitroflow DL Post Approval Study- North America

Primary Purpose

Aortic Stenosis, Aortic Regurgitation, Aortic Valve Insufficiency

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mitroflow DL
Sponsored by
LivaNova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Stenosis focused on measuring aortic valve replacement, aortic stenosis, aortic steno-insufficiency

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • UCLA Medical Center
  • Sharp Memorial Hospital
  • River City Clinical Research
  • UF Health - Jacksonville
  • Watson Clinic Center for Research
  • Suburban Hospital - John Hopkins Medicine
  • Bay Regional Medical Center
  • St. John Hospital & Medical Center
  • Catholic Medical Center
  • St. Joseph's Regional Medical Center
  • Duke University Medical Center
  • Lankenau Medical Center
  • University of Virginia Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mitroflow DL

Arm Description

Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)

Outcomes

Primary Outcome Measures

Rate of structural Valve Deterioration in Implanted Patients
To establish rates of structural valve deterioration through 8 years follow-up

Secondary Outcome Measures

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 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)
Hemodynamic Performance
To evaluate the hemodynamic performance of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature
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

Full Information

First Posted
January 22, 2015
Last Updated
February 18, 2020
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT02351726
Brief Title
Mitroflow DL Post Approval Study- North America
Official Title
Mitroflow Aortic Pericardial Heart Valve With Phospholipid Reduction Treatment Post Approval Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor business decision
Study Start Date
March 2015 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Stenosis, Aortic Regurgitation, Aortic Valve Insufficiency, Heart Valve Diseases, Cardiovascular Abnormalities, Cardiovascular Diseases, Congenital Abnormalities, Heart Diseases, Pathological Conditions, Anatomical
Keywords
aortic valve replacement, aortic stenosis, aortic steno-insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mitroflow DL
Arm Type
Experimental
Arm Description
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
Intervention Type
Device
Intervention Name(s)
Mitroflow DL
Other Intervention Name(s)
Mitroflow Pericardial Aortic Heart Valve with PRT
Intervention Description
Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
Primary Outcome Measure Information:
Title
Rate of structural Valve Deterioration in Implanted Patients
Description
To establish rates of structural valve deterioration through 8 years follow-up
Time Frame
8 years
Secondary Outcome Measure Information:
Title
Early and Late Valve-Related Adverse Event Rates
Description
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
Time Frame
Early (30 days) and Late (> 30 days)
Title
Early and Late Rates of hemolysis, non-structural valve dysfunction, valve-related embolism, re-operation, explant and death
Description
To determine rates of hemolysis, non-structural dysfunction, valve-related embolism, reoperation, explant and death (all cause and valve-related)
Time Frame
Early (30 days) and Late (> 30 days)
Title
Hemodynamic Performance
Description
To evaluate the hemodynamic performance of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature
Time Frame
8 years
Title
Improvements in NYHA
Description
To evaluate the overall improvements in patient condition by comparison of pre-operative and post-operative New York Heart Associate (NYHA) functional classification
Time Frame
8 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients is indicated for Mitroflow DL implantation according to the Instructions for Use (IFU). Patient or patient's legal representative is willing to sign the informed consent. Patient's preoperative evaluation indicated the need for native or prosthetic aortic valve replacement 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 Patient is able to return for all follow-up evaluations for the duration of the study (geographically stable). Exclusion Criteria: Patient is contra-indicated for Mitroflow DL implantation according to the Instructions for Use. The patient has a pre-existing valve prosthesis in the mitral, pulmonary, or tricsupid position. Patient requires a double or triple valve replacement (repair is not considered an exclusion). Patient has active endocarditis or myocarditis. Patient is pregnant or lactating. Patient is participating in a concomitant research study of an investigational product.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Kern, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
River City Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
UF Health - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Watson Clinic Center for Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Suburban Hospital - John Hopkins Medicine
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Bay Regional Medical Center
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
St. John Hospital & Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Catholic Medical Center
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03102
Country
United States
Facility Name
St. Joseph's Regional Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
University of Virginia Medical Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

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