Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00853632
• Other study ID #: 2006-05
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2007
• Est. completion date: June 2024

Study information

• Verified date: January 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 329
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Failure
• Mitral Valve Incompetence
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• CEP MAGNA MITRAL PERICARDIAL BIOPROSTHESES
Mitral valve replacement

Locations

Country	Name	City	State
Austria	Krankenhaus Hietzing	Vienna
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Quebec
Canada	St. Paul's Hospital	Vancouver	British Columbia
Germany	University Clinica Eppendorf	Hamburg
Germany	Klinikum der Friedrich Schiller University	Jena
United States	University of Michigan Medical School	Ann Arbor	Michigan
United States	Northwestern University Hospital	Chicago	Illinois
United States	Spectrum Health Hospitals	Grand Rapids	Michigan
United States	University of Iowa Hospital & Clinics	Iowa City	Iowa
United States	North Shore University Hospital, NY	Manhasset	New York
United States	Long Island Jewish Medical Center	New Hyde Park	New York
United States	AdventHealth Orlando	Orlando	Florida
United States	Dignity Health Research Institute	Sacramento	California
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Iowa Heart Medical Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Germany, 

Outcome

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