Coronary Artery Disease Clinical Trial
Official title:
Carpentier-Edwards® Perimount Magna® Mitral Pericardial Bioprostheses Models 7000/7000 TFX and Carpentier-Edwards® Perimount Magna® Mitral Easeā¢ Pericardial Bioprostheses Models 7200TFX and 7300/7300TFX
Verified date | January 2024 |
Source | Edwards Lifesciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Edwards Lifesciences |
United States, Austria, Canada, Germany,
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 |
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