Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

Sponsor

Edwards Lifesciences (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT00853632

Collaborator

(none)

250

Enrollment

Locations

Arm

202

Duration (Months)

16.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Mitral Valve Regurgitation Mitral Valve Incompetence Heart Failure	Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2007

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Device - CEP Mitral Valve	Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES Mitral valve replacement Other Names: Magna Mitral 7000/7000TFX, Magna Mitral Ease 7200TFX, 7300/7300TFX

Arm

Intervention/Treatment

Other: Device - CEP Mitral Valve

Device: CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES

Mitral valve replacement

Other Names:

Magna Mitral 7000/7000TFX, Magna Mitral Ease 7200TFX, 7300/7300TFX

Outcome Measures

Primary Outcome Measures

Primary Safety Endpoints [Long term safety performance]
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 [8 years post-implant]
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 [Long term safety performance]
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 [6 month, 1 year and annual follow-up visits]
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 [8 years post-implant]
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 [6 months post-implant]
Quality of Life Survey (EQ-5D) at 6 month post index procedure as compared to preoperative baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dignity Health Research Institute	Sacramento	California	United States	95816
2	AdventHealth Orlando	Orlando	Florida	United States	32803
3	Northwestern University Hospital	Chicago	Illinois	United States	60611
4	University of Iowa Hospital & Clinics	Iowa City	Iowa	United States	52242
5	Iowa Heart Medical Center	West Des Moines	Iowa	United States	50266
6	University of Michigan Medical School	Ann Arbor	Michigan	United States	48109
7	Spectrum Health Hospitals	Grand Rapids	Michigan	United States	49503
8	Missouri Baptist Medical Center	Saint Louis	Missouri	United States	63131
9	North Shore University Hospital, NY	Manhasset	New York	United States	11030
10	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
11	Krankenhaus Hietzing	Vienna		Austria	A-1130
12	St. Paul's Hospital	Vancouver	British Columbia	Canada	V6Z 1Y6
13	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Quebec		Canada	G1V4G5
14	University Clinica Eppendorf	Hamburg		Germany	20246
15	Klinikum der Friedrich Schiller University	Jena		Germany	07740