Clinical trial NCT00853632: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 329
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Subject's Rate of Objective Performance Criteria Per ISO 5840-2005 - Total Number of Late Adverse Events (by Category) Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort
timeFrame: Events occurring ≥ 31 days and up through 8 years post-implant
measure: Primary Effectiveness Endpoints
timeFrame: 8 years post-implant
Secondary outcomes:
measure: Percent of Early Adverse Events
timeFrame: Events occurring within 30 days of procedure
measure: Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time
timeFrame: 6 months post-implant
measure: Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Magna Mitral Valve Implanted Cohort
timeFrame: Events occurring ≥ 31 days and up through 8 years post-implant
measure: Subject's Average Mean Gradient Measurement
timeFrame: Baseline and 8 years post-implant
measure: Subject's Average Peak Gradient Measurement
timeFrame: Baseline and 8 years post-implant
measure: Subject's Average Effective Orifice Area (EOA) Measurement
timeFrame: Baseline and 8 years post-implant
measure: Subject's Average Effective Orifice Area Index (EOAI) Measurement
timeFrame: Baseline and 8 years post-implant
measure: Subject's Average Cardiac Output Measurement
timeFrame: Baseline and 8 years post-implant
measure: Subject's Average Cardiac Index Measurement
timeFrame: Baseline and 8 years post-implant
measure: Subject's Average Left Ventricular Mass Regression
timeFrame: Baseline and 8 years post-implant
measure: Subject's Average Red Blood Cell Count
timeFrame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
measure: Subject's Average White Blood Cell Count
timeFrame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
measure: Subject's Average Hemoglobin Count
timeFrame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
measure: Subject's Average Hematocrit Count
timeFrame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
measure: Subject's Average Reticulocytes Percentage Over Time
timeFrame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
measure: Subject's Average Platelet Count Over Time
timeFrame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
measure: Subject's Average Serum Lactate Dehydrogenase (LDH) Over Time
timeFrame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
measure: Subject's Average Plasma Free Hemoglobin Over Time
timeFrame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
measure: Subject's Average Haptoglobin Over Time
timeFrame: 6-month, 1-year, 2-year, 3-year, 4-year, 5-year, 6-year, 7-year, and 8-year follow-up visits
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Dignity Health Research Institute
state: California
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Chicago
country: United States
facility: Northwestern University Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospital & Clinics
state: Iowa
city: West Des Moines
country: United States
facility: Iowa Heart Medical Center
state: Iowa
city: Ann Arbor
country: United States
facility: University of Michigan Medical School
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health Hospitals
state: Michigan
city: Saint Louis
country: United States
facility: Missouri Baptist Medical Center
state: Missouri
city: Manhasset
country: United States
facility: North Shore University Hospital, NY
state: New York
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
city: Vienna
country: Austria
facility: Krankenhaus Hietzing
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
city: Hamburg
country: Germany
facility: University Clinica Eppendorf
city: Jena
country: Germany
facility: Klinikum der Friedrich Schiller University
Study officials:
References: