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Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

Primary Purpose

Coronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Mitral valve, pericardial bioprostheses, PERIMOUNT, bovine pericardial leaflets, mitral valve replacement, mitral valve regurgitation, Heart valve disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.
  • The patient has signed and dated the subject informed consent form prior to surgery.
  • The patient is expected to survive the surgery and be discharged.
  • The patient is geographically stable and agrees to attend follow-up assessments.
  • The patient is 18 years or older.

Exclusion Criteria:

  • The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
  • The patient presents with active endocarditis within the last 3 months.
  • The patient is pregnant or lactating.
  • The patient is an intravenous drug abuser.
  • The patient is currently a prison inmate.
  • The patient is currently participating in a study of an investigational drug or device.
  • The patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.
  • The patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve (i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)*.
  • The patient was previously enrolled in the study.
  • The patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ.

Sites / Locations

  • Dignity Health Research Institute
  • AdventHealth Orlando
  • Northwestern University Hospital
  • University of Iowa Hospital & Clinics
  • Iowa Heart Medical Center
  • University of Michigan Medical School
  • Spectrum Health Hospitals
  • Missouri Baptist Medical Center
  • North Shore University Hospital, NY
  • Long Island Jewish Medical Center
  • Krankenhaus Hietzing
  • St. Paul's Hospital
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • University Clinica Eppendorf
  • Klinikum der Friedrich Schiller University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Device - CEP Mitral Valve

Arm Description

Outcomes

Primary Outcome Measures

Primary Safety Endpoints
Long term safety performance will be evaluated by comparing the linearized rates listed below to the objective performance criteria referenced in ISO 5840- 2005, Cardiovascular Implants-Cardiac Valve Prostheses. Thromboembolism All Hemorrhage All Perivalvular Leak Endocarditis
Primary Effectiveness Endpoints
The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant.

Secondary Outcome Measures

Secondary Safety Endpoints
Early & late linearized & actuarial analysis of: Thromboembolism Valve thrombosis All hemorrhage Major hemorrhage All perivalvular leak Major perivalvular leak Endocarditis Hemolysis Structural valve deterioration Non-structural valve dysfunction Reoperation Explant Death Valve-related death
Secondary Safety Endpoints
Blood studies including white blood count, red blood count, hematocrit, plasma free hemoglobin (or haptoglobin and SLDH), platelet and reticulocyte counts will be used to evaluate the rate of hemolysis and adverse events at the 6 month, 1 year and annual follow-up visits.
Secondary Effectiveness Endpoints
The secondary Effectiveness endpoints will be: Hemodynamic Performance by echocardiography at 8 years post implant, which includes: Peak Gradient Mean Gradient Effective Orifice Area Effective Orifice Area Index Performance Index Cardiac Output Cardiac Index Severity of Valvular Regurgitation LV Mass Regression
Secondary Effectiveness Endpoints
Quality of Life Survey (EQ-5D) at 6 month post index procedure as compared to preoperative baseline.

Full Information

First Posted
February 26, 2009
Last Updated
February 15, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT00853632
Brief Title
Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol
Official Title
Carpentier-Edwards® Perimount Magna® Mitral Pericardial Bioprostheses Models 7000/7000 TFX and Carpentier-Edwards® Perimount Magna® Mitral Ease™ Pericardial Bioprostheses Models 7200TFX and 7300/7300TFX
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2007 (undefined)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards® PERIMOUNT Magna Mitral Valves in patients undergoing mitral valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.
Detailed Description
This is a prospective, single-arm, multi-center study to be conducted in the US and outside the US (OUS). Approximately 250 subjects are planned to be enrolled to obtain long term data from 101 subjects at 8 years post implant of the Magna mitral valve. Of these 250, approximately 38 (15%) are anticipated to be simultaneous aortic and mitral replacements. Subject enrollment will not start in the US before obtaining FDA approval of this post market study. Assessments will be obtained for the preoperative and operative visits, and postoperatively at discharge, six months, 1-year and annually thereafter for a minimum of 8 years. Subject's demographics (date of birth, sex), physical assessment (heart rate, height, weight, systolic and diastolic blood pressures), New York Heart Association (NYHA) functional class, cardiac rhythm, cardiovascular medical history/risk factors, non-cardiovascular conditions, previous cardiovascular procedures/interventions, antithromboembolic and lipid lowering medications and coagulation profile. Blood data will be collected from each subject preoperatively, at 6 months and annually post implant through 8 year follow-ups. Echocardiographic evaluation required for each subject preoperatively, at discharge, 6 months (between 3-6 months), 1, 2, 4, 6, and 8 year follow-ups. A QOL survey (EQ-5D) will be completed by the subject pre-operatively and at the 6-month follow-up visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Mitral Valve Regurgitation, Mitral Valve Incompetence, Heart Failure
Keywords
Mitral valve, pericardial bioprostheses, PERIMOUNT, bovine pericardial leaflets, mitral valve replacement, mitral valve regurgitation, Heart valve disease

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Device - CEP Mitral Valve
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
Other Intervention Name(s)
Magna Mitral 7000/7000TFX, Magna Mitral Ease 7200TFX, 7300/7300TFX
Intervention Description
Mitral valve replacement
Primary Outcome Measure Information:
Title
Primary Safety Endpoints
Description
Long term safety performance will be evaluated by comparing the linearized rates listed below to the objective performance criteria referenced in ISO 5840- 2005, Cardiovascular Implants-Cardiac Valve Prostheses. Thromboembolism All Hemorrhage All Perivalvular Leak Endocarditis
Time Frame
Long term safety performance
Title
Primary Effectiveness Endpoints
Description
The primary effectiveness endpoint will be the percentage of subjects in NYHA functional classification I or II at 8 years post-implant.
Time Frame
8 years post-implant
Secondary Outcome Measure Information:
Title
Secondary Safety Endpoints
Description
Early & late linearized & actuarial analysis of: Thromboembolism Valve thrombosis All hemorrhage Major hemorrhage All perivalvular leak Major perivalvular leak Endocarditis Hemolysis Structural valve deterioration Non-structural valve dysfunction Reoperation Explant Death Valve-related death
Time Frame
Long term safety performance
Title
Secondary Safety Endpoints
Description
Blood studies including white blood count, red blood count, hematocrit, plasma free hemoglobin (or haptoglobin and SLDH), platelet and reticulocyte counts will be used to evaluate the rate of hemolysis and adverse events at the 6 month, 1 year and annual follow-up visits.
Time Frame
6 month, 1 year and annual follow-up visits
Title
Secondary Effectiveness Endpoints
Description
The secondary Effectiveness endpoints will be: Hemodynamic Performance by echocardiography at 8 years post implant, which includes: Peak Gradient Mean Gradient Effective Orifice Area Effective Orifice Area Index Performance Index Cardiac Output Cardiac Index Severity of Valvular Regurgitation LV Mass Regression
Time Frame
8 years post-implant
Title
Secondary Effectiveness Endpoints
Description
Quality of Life Survey (EQ-5D) at 6 month post index procedure as compared to preoperative baseline.
Time Frame
6 months post-implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient requires, as indicated in the preoperative evaluation, a replacement mitral valve. The patient has signed and dated the subject informed consent form prior to surgery. The patient is expected to survive the surgery and be discharged. The patient is geographically stable and agrees to attend follow-up assessments. The patient is 18 years or older. Exclusion Criteria: The patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year. The patient presents with active endocarditis within the last 3 months. The patient is pregnant or lactating. The patient is an intravenous drug abuser. The patient is currently a prison inmate. The patient is currently participating in a study of an investigational drug or device. The patient requires replacement of a native or prosthetic tricuspid or pulmonic valve. The patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available Carpentier-Edwards PERIMOUNT Valve (i.e. models 2700, 2700TFX, 2800, 2800TFX, 2900, 3000, 3000TFX, 3300TFX)*. The patient was previously enrolled in the study. The patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Currin, PhD
Organizational Affiliation
Edwards Lifesciences
Official's Role
Study Director
Facility Information:
Facility Name
Dignity Health Research Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Northwestern University Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Iowa Hospital & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Iowa Heart Medical Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
University of Michigan Medical School
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Spectrum Health Hospitals
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
North Shore University Hospital, NY
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Krankenhaus Hietzing
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
City
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Facility Name
University Clinica Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Klinikum der Friedrich Schiller University
City
Jena
ZIP/Postal Code
07740
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available to other researchers.

Learn more about this trial

Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

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